CARDIOHELP-i Heart-Lung Support System not properly tested for leakage current
The CARDIOHELP-i Heart-Lung Support System was not properly tested to measure leakage current, an electrical safety concern. The FDA is recalling 1,594 units distributed worldwide.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. While untested electrical leakage current on a critical cardiac device represents a potential safety concern, the absence of reported harm and the Class III classification support a Moderate severity score per the rubric.
Plain-English summary
The CARDIOHELP-i Heart-Lung Support System is an extracorporeal blood oxygenation and carbon dioxide removal device used to provide circulatory and/or pulmonary support during cardiopulmonary bypass procedures. Approximately 1,594 units were affected by this recall.
The system was not properly tested to measure leakage current, an electrical safety parameter. This testing deficiency prompted the recall by manufacturer Maquet Medical Systems USA.
The affected devices are identified by UDI-DI numbers 04058863074863 and 04037691658384, with serial numbers up to and including 90415172. Healthcare facilities with these devices should verify the serial number against the recall notice and contact Maquet Medical Systems USA for guidance on replacement or repair. The devices were distributed worldwide to hospitals and medical facilities.
The recalled product
- Product
- CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF…
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- Affected units
- 1,594
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
- 04037691658384 All serial numbers up to and including 90415172
Distribution
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