FDA Device recall Z-1043-2022
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only by Medtronic Vascular, citing packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1043-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-23 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Vascular |
| Distribution | US |
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.
Identifiers
| code_info | Lot Number: 0010990608/ GTIN: 00763000232580 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1043-2022%22
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