Device product
Vasoshield Syringe Packs, Model VH-5001
Z-0996-2023
Product summary
- Event
- Event 91363
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 530 units US, 215 units OUS
- Official record key
device-enforcement:Z-0996-2023
Official wording
Reason: Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.
Code information: UDI-DI: 00607567700468; Serial Numbers: 25147126, 25151632, 25152389, 25152964, 25163138, 25162077
Distribution pattern: US Nationwide. Japan, Germany.
Derived failure modes
-
Foreign material or chemical contamination
foreign body