Maquet CS 300 Intra-Aortic Balloon Pump Recalled Due to Device Failure
Maquet Datascope is recalling 12,319 CS 300 Intra-Aortic Balloon Pumps because electrical test failures caused the device to fail to pump, which has been associated with a patient death.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that the device failure has been associated with a patient death. Per the severity rubric, if reported deaths exist anywhere in the source text, the score is 5 regardless of other factors.
Plain-English summary
Maquet Datascope Corp - Cardiac Assist Division is recalling 12,319 units of the CS 300 Intra-Aortic Balloon Pump. The recall covers units distributed worldwide in over 100 countries, including nationwide distribution in the United States. The specific product codes involved are 0998-XX-3023-XX and 0998-UC-3023-XX.
The recall was initiated because the device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure. The source text states that this failure to initiate therapy has been associated with a patient death.
Healthcare facilities and users of the CS 300 Intra-Aortic Balloon Pump should stop using the affected units and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- CS 300 Intra-Aortic Balloon Pump
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Category
- Medical Device — Cardiac Assist
- Hazard
- Affected units
- 12,319
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 (1)
- 0998-XX-3023-XX 0998-UC-3023-XX
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Maquet Datascope Corp - Cardiac Assist Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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