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MAQUET CARDIOHELP recallZ-0605-2024 · Maquet Medical Systems USA · initiated Nov 13, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Medical Systems USA or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-0605-2024
Status
Open, Classified
Initiated by the company
Nov 13, 2023
Posted by the FDA
Dec 21, 2023
Recalling firm
Maquet Medical Systems USA
Quantity
1213 US, 2589 OUS
Product code
DTQ
FDA submissions
K133598
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 description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K133598 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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