Medtronic IN — Class II medical device recall Z-1043-2022
Ongoing recall by Medtronic Vascular, Inc., reported 2022-05-18, distributed nationwide. Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
| Recall number | Z-1043-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Inc., Santa Rosa, CA, United States |
| Recall initiated | 2022-03-23 |
| Classified | 2022-05-06 |
| Reported by FDA | 2022-05-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CL, CO, CY, DE, DK, DZ, EG, ES, FI, FR, GB, GR, HK, HN, HR, ID, IE, IL, IN, IT, JP, KR, KW, LB, LU, MX, MY, NL, NO, NZ, OM, PE, PH, PL, PT, SE, SG, SI, TH, TR, TW, UA, ZA |
| Quantity | 3 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00763000232580 |
| Lot numbers | 0010990608 |
| Model numbers | IAV06008008P |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1043-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.