Official recall record
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-02-20
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00699753001534
- Brand on record
- Terumo Cardiovascular Systems Corporation
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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