Venous probe connection cable defects in Cardiohelp-i extracorporeal support systems
Maquet Medical Systems USA is recalling venous probe connection cables for the Cardiohelp-i System due to insulation and wire breaks. Defective cables may prevent the system from receiving critical blood flow and temperature information.
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: FDA Class II recall of critical cardiac support equipment with confirmed cable defects that prevent vital patient monitoring. No illnesses or injuries have been reported, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Medical Systems USA is recalling venous probe connection cables (model references 701069333 and 701048804) used with the Cardiohelp-i System, which provides extracorporeal cardiac support. The recall affects 1,213 units distributed domestically in the United States and 2,589 units distributed internationally.
The company received complaints of breaks in the insulation, shielding, and wires of the connection cables. A fracture in the cable may prevent the Cardiohelp-i System from receiving information from the venous probe, potentially compromising patient care.
If the system does not receive proper data from the venous probe, patients may be exposed to inappropriate blood flow rates, incorrect blood temperature management, or inaccurate hematocrit and hemoglobin monitoring. These monitoring failures could affect the management of the patient's extracorporeal support.
Healthcare facilities using these cables should contact Maquet Medical Systems USA for replacement or return instructions. Do not use affected cables with serial numbers up to and including 90413927.
The recalled product
- Product
- Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- cable-fracture
- insulation-defect
- monitoring-loss
- equipment-malfunction
Distribution
Distributed nationwide across the United States.
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