Medtronic IN — Class II medical device recall Z-1042-2022
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-1042-2022 |
|---|---|
| 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 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00643169383258, 00643169383265, 00643169383272, 00643169383340, 00643169383357, 00643169383364, 00643169383500, 00643169383524, 00643169383531, 00643169383609, 00643169383616, 00643169383623, 00643169576315, 00643169576353, 00643169740181, 00643169740204, 00643169740297, 00643169740334, 00643169740396, 00643169740402, 00643169740426, 00643169740440, 00643169740464, 00643169740488, 00643169777712 and 13 more |
| Model numbers | ADM04004013P, ADM04008013P, ADM04012013P, ADM04015013P, ADM04025013P, ADM05004013P, ADM05006013P, ADM05008013P, ADM05020013P, ADM06004013P, ADM06006013P, ADM06008013P, ADM06012013P, ADM06015013P, ADM07004013P, ADM07006013P, ADM07008013P, SBI04004013P, SBI04008008P, SBI04012013P, SBI04015013P, SBI05004008P, SBI05006013P, SBI05012008P, SBI05012013P and 12 more |
Product
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM04025013P ADM05004013P ADM05004013P ADM05006013P ADM05006013P ADM05008013P ADM05008013P ADM05020013P ADM06004013P ADM06004013P ADM06006013P ADM06006013P ADM06008013P ADM06012013P ADM06015013P ADM06015013P ADM06015013P ADM06015013P ADM07004013P ADM07006013P ADM07006013P ADM07008013P SBI04004013P SBI04008008P SBI04012013P SBI04015013P SBI05004008P SBI05006013P SBI05012008P SBI05012008P SBI05012013P SBI05015013P SBI06004008P SBI06004008P SBI06004013P SBI06004013P SBI06006008P SBI06006008P SBI06008008P SBI06008008P SBI06012013P SBI06012013S SBI06015013P SBI07004013P SBI08004013P SBI08008008S SBI10004008P
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-1042-2022. 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.