Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic IN.PACT AV Recalled by Medtronic Vascular, Inc. Due to Packaging for Balloon Catheters may be damaged resulting...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Vascular, Inc. directly.
Affected Products
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Quantity: 3 units
Why Was This Recalled?
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Vascular, Inc.
Medtronic Vascular, Inc. has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report