Class 2 Device Recall MEGA IAB CATHETER

• Date Initiated by Firm: September 17, 2024
• Date Posted: November 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0311-2025
• Recall Event ID: 95396
• 510(K)Number: K041281 K112327 K133074
• Product Classification: System, balloon, intra-aortic and control - Product Code DSP
• Product: MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
• Code Information: UDI-DI: 10607567107974; Lot Number: 3000344298
• FEI Number: 1000222374
• Recalling Firm/ Manufacturer: Datascope Corp.; 15 Law Dr Unit 1; Fairfield NJ 07004-3206
• For Additional Information Contact: Marc De Carlo; 973-709-7725
• Manufacturer Reason for Recall: There is discrepant labeling on the inner and outer packaging of the device.
• FDA Determined Cause: Error in labeling
• Action: An URGENT MEDICAL DEVICE REMOVAL notification letter was sent to customers beginning 9/23/24. Actions to be taken by the user: Our records indicate that you have received one or more of the affected MEGA 7.5Fr 40cc IAB devices. Please examine your inventory immediately to determine if you have any impacted product. See pictures of the outer cartons for the potentially impacted product below. Please verify all labels, IFU, and IAB against the artwork on the outer carton. If the product, IFU, and labels all match the information for the MEGA 7.5Fr 40cc outer carton (circled green in the second picture below), the device can be used as indicated in the IFU and does not need to be returned. If the outer carton states that Lot 3000344298 is a 50cc size (circled red in the first picture below), then this is incorrect and you should return the affected device by contacting Getinge QRC on QRC.UKI@getinge.com. Please forward this information to all current and potential Datascope/Getinge IAB users within your hospital/facility. If you are a distributor who has shipped any affected products to customers, please forward this letter to their attention for appropriate action. Whether or not you have any impacted product, complete and sign the attached Response Form (Page 5) to acknowledge that you have received and understand this notification. Return the completed form to Datascope/Getinge by e-mailing a scanned copy or by faxing the form to your local Datascope/Getinge Representative or office. Actions to be taken by Getinge: Datascope/Getinge is initiating this Urgent Medical Device Removal to notify users of this IAB labeling issue. This voluntary removal only affects the products identified above that are manufactured for lot number 3000344298; no other products are affected. Email: QRC.UKI@getinge.com
• Quantity in Commerce: 160 units
• Distribution: International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
• 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 = DSP; 510(K)s with Product Code = DSP