Recall Record

Temecula, CA, United States

Abbott Vascular recalls

8 recalls recorded since 2018, most recently on 6 November 2024. 4 are listed as ongoing. Status and classification are as published by the FDA.

Recalls8
Ongoing (FDA)4
Terminated or completed4
Class I (FDA)2

Ongoing Class II Medical devices

Recall started
6 November 2024
Reason
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Distribution
US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC. OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0732-2025, Z-0731-2025, Z-0730-2025, Z-0733-2025

Ongoing Class II Medical devices

Recall started
8 September 2022
Reason
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
Distribution
Worldwide distribution - US Nationwide including in the states of PR, WA, NE, MO, IA, KS, TN, MN, ND, MD, VA, MA, PA, DC, LA, KY, CA, NV, IL, WI, TX, CT, VT, AL, AR, GA, MS, MI, OH, FL, NC, NJ, CO, NY, DE, OR, SC, IN, HI, AZ, NH, ME, WV, OK, ID, UT, MT, NM, RI, AK, SD and the countries of AE, AR, AT
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0115-2023, Z-0116-2023, Z-0117-2023

Ongoing Class I Medical devices

Recall started
30 March 2022
Reason
There is a potential that the proximal marker may separate from the imaging catheter
Distribution
US:AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD ME MI MN MO MT NC NE NH NJ NM NV NY OH OK OR PA PR RI SC TN TX UT VA VT WA WI, PR OUS: AE, AT, AW, BE, CA, CH, DE, DK, IT, JP, LU, NL, NO, NZ, PL, EE, ES, FI, FR, GB, HK, HU, IE, PT, RO, SE, SG, SI, TH
Initiated
Voluntary: Firm initiated
Recall number
Z-1095-2022

Ongoing Class II Medical devices

Recall started
11 March 2022
Reason
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Distribution
U.S Nationwide Distribution.: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, VA, WA, and WI. O.U.S.: United Arab Emirates, France, Pakistan, Argentina, United Kingdom, Portugal, Austr
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0925-2022, Z-0924-2022, Z-0921-2022, Z-0922-2022, Z-0923-2022

Terminated Class II Medical devices

Recall started
25 March 2020
Terminated
12 July 2021
Reason
Incorrect expiration date
Distribution
US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee
Initiated
Voluntary: Firm initiated
Recall number
Z-2370-2020

Terminated Class I Medical devices

Recall started
29 January 2020
Terminated
16 April 2024
Reason
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Distribution
Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1142-2020, Z-1132-2020, Z-1133-2020, Z-1143-2020, Z-1141-2020, Z-1136-2020, Z-1131-2020, Z-1134-2020, Z-1129-2020, Z-1135-2020, Z-1140-2020, Z-1139-2020 and 5 more

Terminated Class II Medical devices

Recall started
1 May 2019
Terminated
11 December 2020
Reason
Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention.
Distribution
U.S.: FL, UT, IN, OK, TX, CO, LA, AZ, MO, AL, GA, CA, AR, KS, IL, HI, IA, KY, MA, DC, NY, NV, NM, NJ, MT, MD, NC, CT, MI, MN, OH, ND, NH, OR, PA, WI, WA, VA, WV, TN, SC, RI, DE, ME, NE, SD, MS, ID, VT. Foreign (OUS): AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, Canada, CROATIA, CZECH REPUBLIC, DENMARK,
Initiated
Voluntary: Firm initiated
Recall number
Z-1687-2019

Terminated Class II Medical devices

Recall started
3 July 2018
Reason
Incorrect expiration being entered for one lot.
Distribution
US Nationwide Distribution - NC and NY
Initiated
Voluntary: Firm initiated
Recall number
Z-0960-2019

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.