Recall Z-0605-2024 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Medical Systems USA
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
| Date | Dec 21, 2023 (initiated Nov 13, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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. |
| Quantity | 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, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133598 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, May 21, 2014 |