CARDIOHELP-i System Recalled for Elevated Patient Leakage Current
Maquet Medical Systems USA is recalling the CARDIOHELP-i System because measured patient leakage current in some units significantly exceeded expected safety levels.
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: FDA Class II medical device for critical cardiac support with measured patient leakage current exceeding safe operating levels. No illnesses or injuries reported in the source; elevated leakage current in a life-support system constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Maquet Medical Systems USA is recalling the CARDIOHELP-i System, a blood oxygenation and carbon dioxide removal device used in critical care settings. The manufacturer identified that patient leakage current in certain devices significantly exceeded expected levels, creating an electrical safety concern.
The recall affects 148 CARDIOHELP-i System units distributed worldwide, with 5 units in the United States located in New Jersey and Texas. The affected devices carry Part Number 70104.8012 and 70104.8012R and are identified by specific serial numbers documented in FDA recall notice Z-1831-2024.
Healthcare facilities with affected devices should discontinue use and contact Maquet Medical Systems USA for instructions regarding device replacement or repair.
The recalled product
- Product
- CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
- Manufacturer
- Maquet Medical Systems USA
- Category
- Medical Device — Cardiac Support
- Hazard
- electrical-leakage
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 (20)
- Part No. 70104.8012 and 70104.8012R
- UDI-DI: 04037691658384
- Serial no. 90410021
- 90410029
- 90410165
- 90410254
- 90410255
- 90410024
- 90410025
- 90410026
- 90410028
- 90410030
- 90410031
- 90410034
- 90410035
- 90410036
- 90410043
- 90410044
- 90410045
- 90410046
Distribution
Distributed nationwide across the United States.
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