MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

FDA device recall Z-0311-2025 · posted 2024-11-05 · Open, Classified

Recall details

Recalling firm

Datascope Corp.

Reason for recall

There is discrepant labeling on the inner and outer packaging of the device.

Action taken

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

Root cause

Error in labeling

Status

Open, Classified

Product code

DSP

Quantity affected

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.

Date initiated

2024-09-17

Date posted

2024-11-05

Location

Fairfield, NJ

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