MEGA Intra-Aortic Balloon Catheter Recalled for Undersized Dilator
Datascope Corporation is recalling 10,427 units of the MEGA 8Fr 50cc Intra-Aortic Balloon Catheter due to an undersized dilator in certain lots. The device has been distributed internationally and is awaiting domestic distribution.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical cardiac support device with a structural defect (undersized dilator), which qualifies as a risk-of-harm product. Per the severity rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Datascope Corporation is recalling certain lots of the MEGA 8Fr 50cc Intra-Aortic Balloon Catheter due to an undersized dilator. The intra-aortic balloon catheter is a medical device used in cardiac support applications.
The recall affects 10,427 units distributed internationally to 23 countries including Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Spain, Sweden, Switzerland, and the United Kingdom. In the United States, the product is awaiting domestic distribution.
The affected product includes certain lots containing an undersized dilator. Patients and healthcare providers should contact Datascope Corporation or the FDA if they have questions about affected units.
The recalled product
- Product
- MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
- Manufacturer
- Datascope Corporation
- Hazard
- device-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Code information reads "UDI-DI
- Lot No.
- Finished Goods Part No.": 10607567109619
- 3000184437
- 0684-00-0296-01U
- 10607567107301
- 3000171501
- 0684-00-0498-01
- 3000183312
- 3000183313
- 3000186654
- 3000186655
- 0684-00-0498-01.
Distribution
Distribution scope not specified by the agency.
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