Reported Jan 12, 2022 · Terminated
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
- Lot codes and dates
- The IFU for all model numbers and serial numbers.
- Amount recalled
- 21,653 devices
Where it was sold
- Nationwide
Why it was recalled
There have been reports of stent migration.
This product could cause temporary or reversible health problems — stop using it.
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