Cardiosave Hybrid IABP Recalled for Potential Therapy Interruption at High Altitudes
Maquet Datascope is recalling Cardiosave Hybrid IABP devices due to a potential inability to start therapy for users at altitudes above 3,200 feet.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Maquet Datascope Corp - Cardiac Assist Division is recalling the Cardiosave Hybrid IABP, Part Number 0998-00-0800-53. The recall is issued because there is a potential for interruption and/or inability to start therapy to the patient prior to or during use of the device for users who are at altitudes above 3,200 feet.
The affected devices were distributed US Nationwide and internationally to 77 countries. The recall includes all serial numbers associated with UDI 10607567108391. The agency has classified this recall as Class I.
Healthcare providers and users should contact the recalling firm for further instructions on how to manage the affected devices.
The recalled product
- Product
- Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Hazard
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)
- UDI - 10607567108391 All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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