Recall Z-1043-2022— Medtronic Vascular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2022-03-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only. Reason: Packaging for Balloon Catheters may be damaged resulting in loss of sterility..
- Recalling firm
- Medtronic Vascular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-23
- Firm location
- Santa Rosa, CA, United States
Product description
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Reason for recall
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.