Reported Nov 3, 2021 · Ongoing
C315-HIS Delivery Catheter
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?
- C315-HIS Delivery Catheter
- Lot codes and dates
- GTIN00763000160180
- ModelC315HIS02 (Serial
- Number/Lot Number0010567341)
- C315HIS03 (Serial Number/Lot Number10568899)
- and C315HIS04 (Serial Number/Lot Number10568900)
- Amount recalled
- 591 units
Why it was recalled
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
This product could cause temporary or reversible health problems — stop using it.
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