Reinforced Introducer Sets Maquet 7 Fr — Class II medical device recall Z-0932-2020
Terminated recall by Datascope Corporation, reported 2020-02-12, distributed in AK, AL, AZ, CA, CO, CT, FL, GA…. Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet
| Recall number | Z-0932-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corporation, Fairfield, NJ, United States |
| Recall initiated | 2019-11-20 |
| Classified | 2020-02-01 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2021-06-15 |
| Distributed | AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV |
| Countries outside the US | AT, CA, CH, DE, ES, IT, MY, NL, PL, ZA |
| Quantity | 102 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10607567106656 |
| Lot numbers | 3000051658 |
| Model numbers | 0403, 0684 |
Product
Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
Reason for recall
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
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-0932-2020. 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.