Maquet CARDIOSAVE IABP Li-Ion Battery Recall Due to Venting Risk
Maquet is recalling Li-Ion batteries for CARDIOSAVE IABP devices after reports of venting when dropped.
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: The recall involves a medical device with a risk of harm (battery venting) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Maquet Datascope Corp is recalling Li-Ion batteries (part number 0146-00-0097) used with the CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP. The recall involves 8,000 units distributed worldwide and in the US.
The recall was initiated after Maquet received three confirmed complaints regarding the batteries venting after being accidentally dropped. The affected devices are electromechanical systems used to inflate and deflate intra-aortic balloons.
Healthcare facilities and users should stop using the affected batteries and contact Maquet for instructions on replacement or return.
The recalled product
- Product
- CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate…
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Category
- Medical Device — Cardiac Assist
- Hazard
- Affected units
- 8,000
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)
- part number 0146-00-0097
Distribution
Distributed nationwide across the United States.
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Similar recalls
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