Maquet Cardiosave Rescue IABP Recalled for High Altitude Therapy Interruption
Maquet Datascope is recalling Cardiosave Rescue IABP devices due to a potential inability to start therapy at altitudes above 3,200 feet.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Maquet Datascope Corp - Cardiac Assist Division is recalling the Cardiosave Rescue IABP, Part Number 0998-UC-0800-83. The recall is classified as Class I by the U.S. Food and Drug Administration.
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 Cardiosave IABP for users who are at altitudes above 3,200 feet. The affected devices have UDI 10607567108407 and include all serial numbers.
The products were distributed US Nationwide and internationally to 77 countries. Users should contact the recalling firm for further instructions regarding the recall.
The recalled product
- Product
- Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
- 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 (1)
- UDI - 10607567108407 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.
See all 2 products in this recall →Related recalls
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