Abbott Vascular recalls

4 official recalls and safety alerts involving Abbott Vascular since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Abbott Vascular or the relevant agency.

  1. 2025-01-01
  2. US
    Drugs & medicalClass II

    Abbott Vascular Inc recalls 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.

    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.

    FDA · DeviceAbbott Vascular IncUS: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA,…Official notice →
  3. 2022-10-26
  4. US
    Drugs & medicalClass II

    Abbott Vascular recalls Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip…

    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.…

    FDA · DeviceAbbott VascularWorldwide distribution - US Nationwide including in the states of PR, WA, NE,…Official notice →
  5. 2022-05-25
  6. US
    Drugs & medicalClass I

    Abbott Vascular recalls Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

    There is a potential that the proximal marker may separate from the imaging catheter

    FDA · DeviceAbbott VascularUS: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…Official notice →
  7. 2022-04-20
  8. US
    Drugs & medicalClass II

    Abbott Vascular recalls Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01…

    Due to an increase in complaint trend for leaks and intermittent/loose connections.

    FDA · DeviceAbbott VascularU.S Nationwide Distribution.: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID,…Official notice →