Plano, TX, United States
Abbott Medical recalls
16 recalls recorded since 2018, most recently on 12 May 2026. 12 are listed as ongoing. Status and classification are as published by the FDA.
Recalls16
Ongoing (FDA)12
Terminated or completed4
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 12 May 2026
- Reason
- Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: Not provided yet
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2405-2026
- Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Ongoing Class II Medical devices
- Recall started
- 6 October 2025
- Reason
- There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0458-2026, Z-0459-2026
- Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
- Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Ongoing Class II Medical devices
- Recall started
- 15 February 2025
- Reason
- Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and the country of Spain. There were five (5) LSP202V devices distributed within the United States (3 in FL, 1 in SC, 1 in WV) that are impacted by this issue, two (2) of which were implanted, see Attachment A.3 for list of s
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1557-2025
- Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Ave
Ongoing Class II Medical devices
- Recall started
- 21 November 2024
- Reason
- Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN TX, UT, VA, WA, WI, and WV. The countries of Austria, Belgium, Canada, Denmar
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0753-2025
- The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, prog
Ongoing Class II Medical devices
- Recall started
- 17 October 2024
- Reason
- A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- Distribution
- New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0495-2025, Z-0492-2025, Z-0491-2025, Z-0494-2025, Z-0493-2025
- Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
- Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
- Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
- Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
- Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Ongoing Class III Medical devices
- Recall started
- 1 October 2024
- Reason
- Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0551-2025, Z-0552-2025
- Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote moni
- Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an im
Ongoing Class II Medical devices
- Recall started
- 22 May 2024
- Reason
- Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, WA, WI, WY and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2432-2024, Z-2429-2024, Z-2430-2024, Z-2431-2024
- Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
- Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
- Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
- Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
Ongoing Class II Medical devices
- Recall started
- 16 May 2024
- Reason
- The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
- Distribution
- Worldwide - US Nationwide distribution including in the states of ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, GUAM, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY, LOUISIANA,MAINE, MARYLAND, MASSACHUSETTS, MICHIGA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2358-2024, Z-2359-2024, Z-2363-2024, Z-2360-2024, Z-2366-2024, Z-2364-2024, Z-2367-2024, Z-2365-2024, Z-2362-2024, Z-2368-2024, Z-2361-2024, Z-2369-2024
- Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
- Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
- Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
- Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
- Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only
- Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
- Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
- Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 16 May 2024
- Reason
- Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.
- Distribution
- US: Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NE, NH, NJ, NY, OH OK, OR, PA, SC, SD, TX, UT, WI, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2265-2024
- Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Ongoing Class II Medical devices
- Recall started
- 5 February 2024
- Reason
- Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. OUS: Pending
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1695-2024
- Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Ongoing Class II Medical devices
- Recall started
- 16 August 2023
- Reason
- Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.
- Distribution
- U.S.: Nation-wide O.U.S.: Australia, Austria, Bahrain, Belgium, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Nepal, Netherlands, New Zealand, Norway, Oman, Polan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2614-2023, Z-2615-2023
- Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CD
- Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Ther
Ongoing Class I Medical devices
- Recall started
- 18 July 2023
- Reason
- Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The count
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2507-2023, Z-2505-2023, Z-2510-2023, Z-2511-2023, Z-2506-2023, Z-2509-2023, Z-2508-2023
- Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electr
- Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected
- Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes
- Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes
- Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or m
- Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrode
- Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electr
Terminated Class II Medical devices
- Recall started
- 9 December 2019
- Terminated
- 14 December 2020
- Reason
- Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
- Distribution
- Worldwide Distributed - US Nationwide in sates of: FL, PA, NY, TX, MI CA, IL, NE, AL, NV, including PR and the countries of: Malaysia, Korea, Paraguay
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0783-2020
- Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Terminated Class II Medical devices
- Recall started
- 9 December 2019
- Terminated
- 11 December 2020
- Reason
- Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of MA, VA, NH, FL, CT, UT, OH, WI, NY, IA, MI, MS, PA, and countries of Canada, Czech Republic
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0789-2020
- Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters,
Terminated Class II Medical devices
- Recall started
- 11 November 2019
- Terminated
- 1 April 2021
- Reason
- A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.
- Distribution
- Worldwide distribution - US Nationwide and country of Bermuda.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0720-2020
- CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet
Terminated Class II Medical devices
- Recall started
- 14 October 2019
- Terminated
- 19 July 2021
- Reason
- Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.
- Distribution
- nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0664-2020
- Radiofrequency Grounding Pad, REF RF-DGP-L
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.