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Use caution Medical device recall · FDA · Published November 13, 2023

Maquet Cardiohelp-i Venous Probe Cable Recall: Insulation Breaks Risk Blood Flow Errors

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.

🇺🇸 FDA recall #Z-0605-2024Medical deviceMaquet Medical Systems ›
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Recalling firmMaquet Medical Systems USA45 Barbour Pond Dr · Wayne, NJ 07470-2094
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/56874-maquet-cardiohelp-i-venous-probe-cable-recall-insulation-breaks-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/56874-maquet-cardiohelp-i-venous-probe-cable-recall-insulation-breaks-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0605-2024

Cite this page

“Maquet Cardiohelp-i Venous Probe Cable Recall: Insulation Breaks Risk Blood Flow Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56874-maquet-cardiohelp-i-venous-probe-cable-recall-insulation-breaks-risk. Based on FDA recall #Z-0605-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0605-2024%22&limit=1).

Maquet Medical Systems USA is voluntarily recalling Venous probe connection cables used with the Cardiohelp-i System, the FDA said on Nov. 13, 2023. The firm initiated the recall after receiving complaints of breaks in the cable's insulation, shielding, or wires.

How to tell if you have it

  • Brand: Maquet Medical Systems
  • Product: Venous probe connection cable used with the Cardiohelp-i System
  • REF: 701069333 and 701048804
  • Part numbers: 701072780 and 701041802
  • UDI-DI: 04058863074863 and 04037691658384
  • Serial numbers: All up to and including 90413927

The hazard

Fracture of the venous probe cable may influence the management of extracorporeal support. Patients 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.

Context

GovInfoNow's records show Maquet Medical Systems USA has 14 other recalls on record since July 14, 2021. Other recent recalls include the Maquet Cardiohelp-i System Recall dated April 15, 2024, and the Maquet BEQ-HLS 7050 Recall dated Jan. 16, 2024. Additional similar product recalls include the Maquet Bubble Sensor Recall on Jan. 9, 2026, the Medline Namic Preceptor Manifold Recall on March 24, 2026, and the Hamilton Medical IntelliCuff Recall on May 22, 2026.

How to tell if you have this one

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.

  • Brand
    Maquet Medical Systems
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Cable Serial Number

    Look for serial numbers up to and including 90413927 on the cable.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Domestic distribution Nationwide. Foreign distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Canada, Cayman Islands, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Nov 13, 202312. FDA classified it Class II: Dec 21, 202323. Published in FDA’s Enforcement Report: Dec 27, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0605-2024 (November 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0605-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA