Recall archive / FDA device enforcement
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter — FDA record Z-1685-2022
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 Aug 5, 2022. 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 8Fr 50cc Intra-Aortic Balloon Catheter
- Reason
- Certain lots containing undersized dilator.
- Classification
- Class II
- Recalling firm
- Datascope Corporation
- Quantity
- 10,427 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1685-2022
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 | Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567109619, 3000184437, 0684-00-0296-01U; 10607567107301, 3000171501, 0684-00-0498-01; 10607567107301, 3000183312, 0684-00-0498-01; 10607567107301, 3000183313, 0684-00-0498-01; 10607567107301, 3000186654, 0684-00-0498-01; 10607567107301, 3000186655, 0684-00-0498-01. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 14, 2022
- Recall initiation date
- Aug 5, 2022
- Center classification date
- Sep 8, 2022
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.