Maquet Cardiohelp Support System Recalled for Unexpected Shutdowns
Maquet is recalling 154 Cardiohelp Support Systems because the touch screen display may shut down unexpectedly and restart automatically.
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: The recall involves a high-risk medical device used for circulatory support where a display failure could compromise patient safety, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling 154 units of the MAQUET CARDIOHELP Support System, specifically the CARDIOHELP-I Software up to version 3.3.0.0. The product is a blood oxygenation and carbon dioxide removal system used to pump blood through an extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass or for periods up to six hours.
The recall was initiated because the human machine interface (HMI), which is the central display of the device where measured values, settings, and alarms are displayed and adjusted, has experienced episodes of brief unexpected shutdown followed by an automatic device restart. The HMI is critical for monitoring the device's operation.
The affected units were distributed worldwide, including the United States and numerous international locations. The catalog number for the affected software is 70104.8012 Cardiohelp-i. Users should contact Maquet Cardiovascular, LLC for instructions on how to address the software issue.
The recalled product
- Product
- MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support
- Manufacturer
- Maquet Cardiovascular, LLC
- Affected units
- 154
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)
- Catalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Maquet Cardiovascular, LLC
See all →- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- HighVessel harvesting systems recalled after out-of-box failures in harvesting tool jaws
FDA (Devices) · 2025-10-01
- HighHeartstring III seal systems recalled over failures to load, deploy and seal
FDA (Devices) · 2025-09-24
- HighHeartstring III 4.3 mm seal systems recalled over loading and deployment failures
FDA (Devices) · 2025-09-24
- HighHeartstring III 3.8 mm seal systems recalled over three identified failure modes
FDA (Devices) · 2025-09-24
Same hazard · software failure
See all →- ModerateFoundation Medicine Recalls Hamilton Microlab STAR Liquid Handler Software
FDA (Devices) · 2026-08-26
- SevereOlympus High Flow Insufflation Unit Recalled Due to Software Overpressure Risk
FDA (Devices) · 2026-02-25
- ModerateStryker Blueprint Mixed Reality Glenoid Box Lid system functionality issues
FDA (Devices) · 2025-04-16
- ModerateStryker Blueprint Mixed Reality Glenoid Pin Guide Impaired Function Recall
FDA (Devices) · 2025-04-16
- HighMerlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing
FDA (Devices) · 2025-01-01