Maquet Recalls Cardiosave Hybrid and Rescue IABP Devices
Maquet is recalling Cardiosave Hybrid and Rescue IABP devices because the scroll compressor may not meet specifications for output pressure or vacuum at specific flow rates.
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: The recall involves a high-risk medical device (Intra-Aortic Balloon Pump) with a functional defect (pressure/vacuum specifications) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Maquet Datascope Corp - Cardiac Assist Division is recalling Cardiosave Hybrid and Rescue IABP devices. The recall involves 1,243 units in the United States and 1,107 units outside the United States. The affected devices were distributed worldwide, including nationwide distribution in the United States and Puerto Rico.
The recall was initiated because Maquet received information that in some of these devices, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates. The specific model codes affected are 0998-00-0800-53, 0998-UC-0800-53 for the Cardiosave Hybrid IABP, and 0998-00-0800-83 & 0998-UC-0800-83 for the Cardiosave Rescue IABP.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any specific injuries or illnesses associated with the defect.
The recalled product
- Product
- Cardiosave Hybrid and rescue IABP
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
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 (3)
- Cardiosave Hybrid IABP 0998-00-0800-53
- 0998-UC-0800-53
- Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83
Distribution
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