Reported May 18, 2022 · Ongoing
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Medtronic Vascular, Inc.
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 Vascular, Inc. · 3576 Unocal Pl · Santa Rosa, CA · 95403-1774
Is this the product you have?
- Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter
- REFIAV06008008P, Sterile EO, Rx Only
- Lot codes and dates
- Lot Number0010990608/
- GTIN00763000232580
- Amount recalled
- 3 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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