Reinforced Introducer Sets Maquet 7 — Class II medical device recall Z-0933-2020
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-0933-2020 |
|---|---|
| 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 | 676 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10607567106694 |
| Lot numbers | 3000014728, 3000019781, 3000031711, 3000040290, 3000043100, 3000053099, 3000079613, 3000086802 |
| Model numbers | 068400040305 |
Product
Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic 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-0933-2020. 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.