Medical device blood oxygenation system recalled due to defective weld
Maquet Medical Systems USA is recalling 1,022 Cardiohelp-i blood oxygenation systems due to an insufficient weld on a critical component that may break under manual force.
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: This is an FDA Class II recall involving a structural integrity defect in a medical device (blood oxygenation system). Although no injuries or illnesses have been reported, the weld defect creates risk of component failure in critical life-support equipment.
Plain-English summary
Maquet Medical Systems USA is recalling 1,022 Cardiohelp-i blood oxygenation and carbon dioxide removal systems distributed nationwide. The affected systems have serial numbers ranging from 90414355 through 90414868.
The recall was initiated after it was found that the weld securing the nut bolt to the slide rail plate was insufficient. This defective weld can allow the nut bolt to break off with slight manual force, potentially affecting the device's structural integrity and function during use.
Healthcare facilities using the Cardiohelp-i system are affected by this recall. Patients and healthcare providers should follow guidance from Maquet Medical Systems USA and the FDA regarding device replacement or continued use.
The recalled product
- Product
- Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
- Manufacturer
- Maquet Medical Systems USA
- Affected units
- 1,022
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 (2)
- UDI-DI: 04058863074863
- Serial Numbers: 90414355 through 90414868
Distribution
Distributed nationwide across the United States.
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