CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report

Venous probe connection cable recalled by Maquet Medical Systems U

Maquet Medical Systems U is recalling Venous probe connection cable (, distributed nationwide in the US. The recall was initiated on 13 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 04058863074863 and 04037691658384 All serial numbers up to and including 90413927

Quantity recalled1213 US, 2589 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0605-2024
FDA event ID: 93563
Recalling firm: Maquet Medical Systems U, Wayne, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 13 Nov 2023
FDA classified: 21 Dec 2023
Reported: 27 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

13 Nov 2023	Recall initiated by company
21 Dec 2023	Classified by FDA	+38 days
27 Dec 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802

Where it was distributed

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 Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Islamic Republic Of Iraq, Italy, Japan, Kazakhstan, Korea, Republic Of Kuwait, Latvia, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Martinique, Mauritius, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.

Nationwide Puerto Rico

Questions about this recall

Is Venous probe connection cable ( recalled?

Yes. Maquet Medical Systems U recalled Venous probe connection cable ( on 13 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0605-2024.

Why was it recalled?

Which lots are affected?

UDI-DI 04058863074863 and 04037691658384 All serial numbers up to and including 90413927

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Maquet Medical Systems U

All 41

Reported	Class	Recall	Company	Reason	Where
22 May 2024Device	CLASS II	Cardiohelp-i System recalled by Maquet Medical Systems U	Maquet Medical Systems U	Packaging Defects	Nationwide
21 Feb 2024Device	CLASS II	Model No. Beq-hls 5050 USA, HLS Set Advanced 5.0, Product Code/Part recalled	Maquet Medical Systems U	Sterility	Nationwide
21 Feb 2024Device	CLASS II	Beq-hls 7050 USA, HLS Set Advanced 0, Product recalled	Maquet Medical Systems U	Sterility	Nationwide
14 Feb 2024Device	CLASS II	Beq-rf-32-Usa RotaFlow Centrifugal Pump recalled	Maquet Medical Systems U	Sterility	Nationwide
14 Feb 2024Device	CLASS II	Bo-rf-32-Usa RotaFlow Centrifugal Pump recalled	Maquet Medical Systems U	Sterility	Nationwide

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