Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump Recalled for Power Supply Malfunction
Maquet Datascope is recalling 1,300 CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps due to power supply malfunctions related to suboptimal thermal management.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 a Class II recall for a high-risk medical device (IABP) where a power supply malfunction could lead to harm, but the source text does not report specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Datascope Corp - Cardiac Assist Division is recalling 1,300 units of the Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP). The recall is due to power supply malfunction complaints related to suboptimal thermal management.
The affected devices were distributed nationwide in the United States. The recall includes specific lot codes listed in the agency documentation. Devices that were serviced with a new or replacement power supply after August 19, 2014, are not affected by this recall.
Healthcare facilities and users should stop using the affected devices and contact the manufacturer for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Category
- Medical Device — Cardiac Assist
- Affected units
- 1,300
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)
- 2014 are not affected.
Distribution
Distributed nationwide across the United States.
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