Recall archive / FDA device enforcement
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 — FDA record Z-0311-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 17, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
- Reason
- There is discrepant labeling on the inner and outer packaging of the device.
- Classification
- Class II
- Recalling firm
- Datascope Corp.
- Quantity
- 160 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0311-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 10607567107974; Lot Number: 3000344298 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 13, 2024
- Recall initiation date
- Sep 17, 2024
- Center classification date
- Nov 5, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.