Cardiovascular Procedure Kits that include High Crack Check Valve PN… — Class II medical device recall Z-1401-2024
Ongoing recall by Terumo Cardiovascular Systems Corporation, reported 2024-04-10, distributed nationwide. Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at appr
| Recall number | Z-1401-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2024-02-20 |
| Classified | 2024-03-29 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, CO, KR, MX, TH, TW |
| Quantity | 20,533 units |
| UPC / GTIN / UDI-DI | 00699753000278, 00699753001534, 00699753008533, 00699753414716, 00699753454880, 00699753458147, 00699753461970, 00699753479227, 00699753481657, 00699753481664, 00699753483248, 00699753484610, 00699753484627, 00699753484696, 00699753484702, 00699753485297, 00699753486669, 00699753487833, 00699753487970, 00699753489202, 00699753489974, 00699753490079, 00699753490109, 00699753490178, 00699753490314 and 143 more |
| Lot numbers | 16010 |
| Model numbers | 16010, 165720, 205307A, 62974, 6375, 65046-03, 65080-06, 65167-06, 65246, 65934-01, 65940-01, 66041-01, 66154-01, 66312, 66342, 66388, 66503-02, 66650, 66852, 70148-02, 70178-06, 70188-05, 70472, 70638-07, 70664-02 and 146 more |
Product
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534 75607 75765 75797 75833 75903 75956 75973 76131 76178 76278 76306 76398 76427 76498 76519 76536 76565 76575 76628 76630 76635 76644 76687 76725 76775 76789 76832 76839 76878 76900 76999 77010 77014 77015 77105 77227 77299 77304 77305 77412 77450 77496 77516 77629 77722 77742 77757 77791 77794 77796 78018 78027 165720 205307A 65046-03 65080-06 65167-06 65934-01 65940-01 66041-01 66154-01 66503-02 70148-02 70178-06 70188-05 70638-07 70664-02 70665-01 70734-03 71064-01 71432-02 71433-01 71546-02 71733-02 71754-04 71801-02 71820-01 71928-06 71934-04 72073-02 72149-01 72226-06 72326-07 73008-02 73346-01 73567-01 73568-01 73776-04 73783-02 73882-03 74172-03 74685-01 74734-01 74833-01 74879-07 74921-02 74965-03 74965-04 74972-01 75030-01 75050-02 75068-01 75159-01 75293-01 75409-01 75409-02 75410-01 75410-02 75540-03 75540-05 75572-01 75642-02 75688-01 75790-02 75834-01 75927-01 75959-01 75972-01 76178-01 76273-01 76278-01 76308-01 76326-02 76372-01 76373-01 76374-01 76376-01 76491-01 76732-02 76873-02 77012-02 77127-01 77316-01 77496-01 77502-01 77521-01 77532-01 77655-01 77791-01 B75409 B75410 B75903 B76178 B76278
Reason for recall
Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention
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-1401-2024. 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.