Maquet recalls Venous probe connection cables (REF 701069333, 701048804) used with Cardiohelp-i System. Broken insulation may cause blood flow errors, risking patient safety during extracorporeal support.
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.
Maquet is recalling specific venous probe connection cables used with the Cardiohelp-i System. Broken insulation in these cables could cause the device to misread blood flow, temperature, or blood cell levels, potentially harming patients during medical treatments.
The recalled cables have insulation that can break, causing the Cardiohelp-i system to not receive signals from the venous probe. This may lead to incorrect blood flow, temperature, or blood cell level readings, which could harm patients during medical procedures.
Patients using the Cardiohelp-i System with the recalled cables are at risk. Healthcare providers who use these cables for extracorporeal support treatments may need to take action.
Check for product reference numbers 701069333 or 701048804 on the cable. The cables are used with the Cardiohelp-i System and have serial numbers up to 90413927.
Look for serial numbers up to and including 90413927 on the cable.
The recall is due to complaints of broken insulation, shielding, or wires in the venous probe connection cable, which could cause the Cardiohelp-i system to misread blood flow, temperature, or blood cell levels.
The official recall notice does not specify a remedy, so contact Maquet Medical Systems USA for guidance.
Check for product reference numbers 701069333 or 701048804 on the cable, and ensure the serial number is up to 90413927.
We’ve drafted a message you can send Maquet Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0605-2024 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-0605-2024 from Maquet Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
