Class 2 Device Recall Cardiohelp System

• Date Initiated by Firm: February 18, 2022
• Create Date: April 08, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0897-2022
• Recall Event ID: 89745
• 510(K)Number: K133598
• Product Classification: Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
• Product: Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product Code/REF Number: 701072780 (Cardiohelp-i)
• Code Information: Serial Numbers for the Cardiohelp-i (Part Number 701072780)as the Transport Guard (701072525) is packaged with the Cardiohelp-i and is not labelled individually Serial Numbers: 90413945, 90414225, 90414226, 90414227, 90414228, 90414229, 90414232, 90414233, 90414234, 90414235, 90414236, 90414237, 90414283, 90414284, 90414285, 90414286, 90414287, 90414288, 90414289, 90414292, 90414293, 90414294, 90414295, 90414296, 90414297, 90414309, 90414310, 90414311, 90414312, 90414317, 90414318, 90414319. UDI: 04058863074863 (Cardiohelp-i)
• FEI Number: 3008355164
• Recalling Firm/ Manufacturer: Maquet Medical Systems USA; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: SAME; 973-709-7000
• Manufacturer Reason for Recall: Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.
• FDA Determined Cause: Process control
• Action: Getinge issued Urgent Medical Device Correction Letter dated 2/18/22 via FedEx 2 day service with signature required. . Letter states reason for recall, health risk and action to take: A general decommissioning of the affected Cardiohelp-i is not required, with the consideration of the following: 1. Please examine your inventory immediately to determine if you have received any Cardiohelp-i products with one of the affected serial numbers. 2. If you have a Cardiohelp-i affected by this field correction, please examine your inventory immediately to locate all Transport Guards used with Cardiohelp-i products. Please ensure that the Transport Guard can be opened and that the cylindrical pin is not loose prior to using the device. If so, the device can continue to be used. If your Transport guard cannot be opened or if the cylindrical pin is loose, please remove from use and place in a quarantine location to avoid future use. This activity should be performed prior to every use until the field correction activities have been completed at your facility by a Getinge Representative. 3. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 5). A Getinge Service Technician will contact the person you list on the Customer Response Form to schedule service for an inspection of your device. Return the completed form to Maquet Cardiopulmonary GmbH /Getinge by emailing a scanned copy to Transportguardpin2022.act@getinge.com or by faxing the form to 1(888) 722-5375. If your Transport Guard displays the issue identified in this notification, it will be replaced at no cost to your facility. 4. Whether or not you have affected product(s) with the serial numbers listed in this notice, please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 5) to acknowledge that you have received this notification, per the instruction in number 3 above. 5. You can also arrange a visit by a Getinge trained or au
• Quantity in Commerce: US: 32 units; OUS 30 units
• Distribution: US Nationwide Distribution: FL, KY, NH, NJ, NY, PA, TX, VA Foreign: Belgium, Canada, Germany, Hungary, Luxemburg, Malaysia, Mexico, Poland, Slovakia, South Africa, South Korea, and Taiwan.
• 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