Maquet CS 100 Intra-Aortic Balloon Pump Recalled Due to Device Failure
Maquet Datascope is recalling 12,319 CS 100 Intra-Aortic Balloon Pumps because electrical and autofill failures prevented the device from initiating therapy, which has been associated with a patient death.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 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 100 Intra-Aortic Balloon Pump. The recall is due to electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure. These specific failures have been associated with a patient death resulting from the device's inability to initiate therapy.
The affected devices were distributed worldwide in over 100 countries, including nationwide distribution in the United States. The recall involves specific product codes 0998-XX-3013-XX and 0998-UC-3013-XX.
Healthcare providers and facilities should stop using the affected devices and contact Maquet Datascope for further instructions on the recall process.
The recalled product
- Product
- CS 100 Intra-Aortic Balloon Pump
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- 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 (2)
- 0998-XX-3013-XX
- 0998-UC-3013-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.
See all 3 products in this recall →Related recalls
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