Z-0605-2024Class II

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

Name: Z-0605-2024 Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers...
Creator: Maquet Medical Systems USA
Published: 2023-11-13
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2023-11-13 / Open, Classified / root cause: design

FDA source

Maquet Medical Systems USA began a recall of Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802 on 2023-11-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0605-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-13
Posted: 2023-12-21
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: On November 13, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE Removal letter. Customers were informed that if they have an older version of the venous probe connection cable, Getinge will replace the cable at no charge to their facility. If the Venous probe connection cable shows any visible indication of breakage or if the CARDIOHELP-i displays an error instructing you to "replace venous probe or cable", please discontinue use and contact Getinge Customer Support at (888) 943-8872 (select option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). Getinge will provide instructions on the return of the cable and arrange for a replacement to be sent at no charge to your facility. Affected CARDIOHELP-i devices do not need to be returned while awaiting replacement of the venous probe cable. As noted in the Service Manual, please check whether there is any visible damage to the venous probe unit and cables before use. Getinge has been distributing a redesigned venous probe cable since April 2019.
Quantity in commerce: 1213 US, 2589 OUS
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 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.
Product codes and lots: UDI-DI 04058863074863 and 04037691658384 All serial numbers up to and including 90413927

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0605-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0605-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21

Product code DTQ

K133598Class IICardiohelp SystemMaquet Cardiopulmonary, AG / cleared 2014-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)