Class 2 Device Recall Cardiohelpi

• Date Initiated by Firm: November 13, 2023
• Date Posted: December 21, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0605-2024
• Recall Event ID: 93563
• 510(K)Number: K133598
• Product Classification: Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
• Product: Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
• Code Information: UDI-DI 04058863074863 and 04037691658384 All serial numbers up to and including 90413927
• Recalling Firm/ Manufacturer: Maquet Medical Systems USA; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: Ms. Allison Jean Kaplan; 973-709-7000
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DTQ