Datascope Corp. MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Brand
Datascope Corp.
Lot Codes / Batch Numbers
UDI-DI: 10607567107974, Lot Number: 3000344298
Products Sold
UDI-DI: 10607567107974; Lot Number: 3000344298
Datascope Corp. is recalling MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 due to There is discrepant labeling on the inner and outer packaging of the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is discrepant labeling on the inner and outer packaging of the device.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026