# FDA recall Z-1401-2024

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2024-02-20.

## 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 

## 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

## Distribution

worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand.

## Key facts

- **Recall number:** Z-1401-2024
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-20
- **Report date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1401-2024

## Citation

> AI Analytics. FDA recall Z-1401-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1401-2024. Source: US FDA. Licensed CC0.

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