CARDIOHELP-i Heart-Lung Support System: Incorrectly Documented Factory Settings
The CARDIOHELP-i Heart-Lung Support System is recalled because factory settings were incorrectly described in the manual. Healthcare providers should verify device settings with the manufacturer.
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 a risk-of-harm product where factory setting misconfigurations could lead to serious patient injury during critical cardiopulmonary support. While this is a Class II recall with no reported illnesses or injuries, the potential for harm from incorrect documentation of critical settings in this high-risk application justifies a High severity rating.
Plain-English summary
The FDA is recalling the CARDIOHELP-i Heart-Lung Support System, a medical device used to provide blood oxygenation and carbon dioxide removal for circulatory and pulmonary support during cardiopulmonary bypass procedures. The system is manufactured by Maquet Medical Systems USA.
Certain factory settings were incorrectly described in the Instructions for Use (IFU). Specifically, the warning limits for PVen and PAux, the default settings for the venous bubble sensor (VBS), and the automatic lock in the Minimized Extracorporeal Circulation (MECC) application were not accurately documented.
Approximately 1,595 units have been distributed worldwide, including throughout the United States and numerous international locations. All serial numbers up to and including 90415177 are affected.
Healthcare facilities and providers using this device should contact Maquet Medical Systems USA immediately to obtain accurate factory setting information. Do not rely on the current Instructions for Use for these specific settings without verification from the manufacturer.
The recalled product
- Product
- CARDIOHELP-i Heart Lung Support System- A 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 Part Number: 701072780…
- Manufacturer
- Maquet Medical Systems USA
- Affected units
- 1,595
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)
- UDI Code: 04058863074863 (CARDIOHELP-I US)
Distribution
Distributed nationwide across the United States.
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