Hemopro 2 with Vasoshield — Class II medical device recall Z-0995-2023
Ongoing recall by Maquet Cardiovascular, LLC, reported 2023-01-25, distributed nationwide. Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. P
| Recall number | Z-0995-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-01-19 |
| Reported by FDA | 2023-01-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, JP |
| Quantity | 9,817 devices |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 00607567700901 |
| Serial numbers | 25152107, 25152204, 25152293, 25152463, 25152771, 25153153, 25153273, 25153366, 25153585, 25153847, 25153960, 25154066, 25154880, 25155262, 25155326, 25155785, 25156245, 25156642, 25157016, 25157085, 25157244, 25157700, 25157898, 25158066, 25158152 and 24 more |
| Model numbers | VH-4001 |
Product
Hemopro 2 with Vasoshield, Model VH-4001
Reason for recall
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.
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-0995-2023. 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.