Plymouth, MN, United States
Abbott recalls
14 recalls recorded since 2018, most recently on 10 September 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls14
Ongoing (FDA)5
Terminated or completed9
Class I (FDA)3
Ongoing Class I Medical devices
- Recall started
- 10 September 2025
- Reason
- Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0112-2026, Z-0110-2026, Z-0109-2026, Z-0113-2026, Z-0111-2026
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
Ongoing Class II Medical devices
- Recall started
- 17 March 2025
- Reason
- Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1643-2025, Z-1644-2025
- Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
- Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Ongoing Class II Medical devices
- Recall started
- 4 March 2024
- Reason
- Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1479-2024, Z-1480-2024
- ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
- Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Ongoing Class II Medical devices
- Recall started
- 28 September 2023
- Reason
- Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.
- Distribution
- US, Taiwan, and Colombia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0209-2024
- Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Ongoing Class I Medical devices
- Recall started
- 12 June 2023
- Reason
- There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2110-2023
- Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Terminated Class II Medical devices
- Recall started
- 9 June 2022
- Terminated
- 14 August 2026
- Reason
- When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1344-2022
- Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Terminated Class II Medical devices
- Recall started
- 28 April 2022
- Terminated
- 18 June 2024
- Reason
- Incorrect product labeling.
- Distribution
- US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1213-2022
- FIRMap" Catheter, 60mm Basket
Terminated Class II Medical devices
- Recall started
- 24 March 2022
- Terminated
- 4 August 2026
- Reason
- Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
- Distribution
- Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0957-2022, Z-0956-2022
- Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
- Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Terminated Class II Medical devices
- Recall started
- 16 November 2021
- Terminated
- 18 June 2024
- Reason
- As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0420-2022
- Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Terminated Class II Medical devices
- Recall started
- 9 November 2021
- Terminated
- 7 August 2024
- Reason
- Instructions for use were updated.
- Distribution
- OUS distribution only
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0895-2022
- Amplatzer Steerable Delivery Sheath
Terminated Class II Medical devices
- Recall started
- 22 May 2020
- Terminated
- 11 February 2021
- Reason
- High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2541-2020
- TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip desi
Terminated Class II Medical devices
- Recall started
- 28 February 2020
- Terminated
- 18 April 2024
- Reason
- Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
- Distribution
- U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no OUS consignees associated to ICDs that were interrogated from January 22, 2020 to
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1700-2020
- Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, an
Terminated Class II Medical devices
- Recall started
- 19 November 2018
- Terminated
- 28 April 2021
- Reason
- The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
- Distribution
- US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, LA, MA, MI, MO, NE, NH, NJ, NY, TN, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1220-2019
- St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit d
Terminated Class I Medical devices
- Recall started
- 5 April 2018
- Terminated
- 15 October 2021
- Reason
- Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.
- Distribution
- Worldwide Distribution -- U.S., including the states of MN, PA, IL, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, OH, NY, GA, VA, FL, OK, MD, ME, SC, IN, LA, OR, WA, AL, CO, IA, KS, KY, UT, DC, and CT; and, the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, Cayman Islands, Colombia,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1774-2018
- Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart
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.