Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 an
FDA device recall Z-0605-2024 · posted 2023-12-21 · Open, Classified
Recall details
- Recalling firm
- Maquet Medical Systems USA
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- DTQ
- Quantity affected
- 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,
- Date initiated
- 2023-11-13
- Date posted
- 2023-12-21
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOHELP SYSTEM (K133598) | Maquet Cardiopulmonary, AG | 2014-05-21 |