CARDIOHELP Emergency Drive Blockage May Impair Cardiac Blood Oxygenation
The FDA is recalling CARDIOHELP Emergency Drive units due to potential blocking that impairs blood flow. Affected patients may experience ischemia and hypoxia from inappropriate low blood oxygen.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recalls require a minimum severity score of 4 per FDA classification rules. While no injuries are reported, the critical cardiac application and serious potential consequences (ischemia and hypoxia) warrant the Severe classification.
Plain-English summary
The FDA is recalling specific CARDIOHELP Emergency Drive units (Part Numbers 701048002 and 701076205) manufactured by Maquet Medical Systems USA. These devices provide blood oxygenation and carbon dioxide removal in emergency cardiac support. The recall affects 69 units among approximately 1,858 distributed in the United States, with additional units distributed internationally.
The recalled devices may experience blocking or impairment of the Emergency Drive that can lead to inappropriate low blood flow in patients. This condition creates a risk of ischemia (tissue damage from reduced blood supply) and hypoxia (inadequate oxygen delivery to tissues).
Affected devices were distributed to healthcare facilities across the United States and internationally. Additional information about specific affected serial numbers is available in the official FDA recall notice.
The recalled product
- Product
- CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
- Manufacturer
- Maquet Medical Systems USA
- Category
- Medical Device
- Hazard
- flow-obstruction
- ischemia
- hypoxia
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 (12)
- Part No. 701048002: UDI - 04037691643526
- Serial Numbers 90425259 to 90425748 (Excluding 90425438
- 90425443
- 90425568
- 90425570
- 90425588
- 90425716) [***Updated 1/8/24 to include Serial numbers 90421507
- 90421980
- Serial Numbers 90425438
- 90425716
- 90425747
- 90425748
Distribution
Distributed nationwide across the United States.
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