← Every firm
Abbott Vascular FDA Recalls
9 recalls on file across devices, 1 of them Class I and 9 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, Class IISep 8, 2022An increase in clip locking malfunctions, Establish Final Ar |
| Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MiClass IISep 8, 2022An increase in clip locking malfunctions, Establish Final Ar |
| Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MClass IISep 8, 2022An increase in clip locking malfunctions, Establish Final Ar |
| Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EOClass IMar 30, 2022There is a potential that the proximal marker may separate f |
| Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 100018Class IIMar 11, 2022Due to an increase in complaint trend for leaks and intermit |
| 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)Class IIMar 11, 2022Due to an increase in complaint trend for leaks and intermit |
| 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)Class IIMar 11, 2022Due to an increase in complaint trend for leaks and intermit |
| INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)Class IIMar 11, 2022Due to an increase in complaint trend for leaks and intermit |
| 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV -Class IIMar 11, 2022Due to an increase in complaint trend for leaks and intermit |