Maquet Datascope Recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps
Maquet Datascope is recalling CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps because fluid ingress can damage electronic circuit boards, preventing therapy initiation or continuation.
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 Hybrid Intra-Aortic Balloon Pump (IABP) and associated cart. The recall covers specific part numbers, excluding 0998-00-0800-83, 0998-UC-0800-83, and 0998-00-0800-75, with serial numbers distributed between March 6, 2012, and April 26, 2018.
The recall was initiated because fluid ingress into the device can affect various electronic circuit boards. This damage would prevent the initiation or continuation of therapy. The devices were distributed to numerous US states and foreign countries.
Healthcare facilities and users should contact Maquet Datascope for instructions on how to handle the affected devices.
The recalled product
- Product
- CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Category
- Medical Device — Cardiac Assist
- Affected units
- 4,300
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)
- All Serial Numbers distributed from 03/06/2012 to 04/26/2018
Distribution
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