MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories… recallZ-0311-2025 · Datascope Corp. · initiated Sep 17, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Datascope Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Error in labeling

What the company is doing

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 [email protected]. 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: [email protected]

Recall details

Recall number: Z-0311-2025
Status: Open, Classified
Initiated by the company: Sep 17, 2024
Posted by the FDA: Nov 5, 2024
Recalling firm: Datascope Corp.
Quantity: 160 units
Product code: DSP
FDA submissions: K133074, K041281, K112327
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.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 10607567107974; Lot Number: 3000344298

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

MEGA 7.5Fr. 40cc IAB 0684-00-0295-01
Datascope Corp. · System, Balloon, Intra-Aortic And Control
2 recalls4 deaths38 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

How recalls are matched to devices · Editorial policy · Report an error on this page