Z-0311-2025Class II

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

Name: Z-0311-2025 MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Creator: Datascope Corp.
Published: 2024-09-17
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2024-09-17 / Open, Classified / root cause: labeling and UDI

FDA source

Datascope Corp. began a recall of MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 on 2024-09-17. FDA classified it as Class II and gives the reason as "There is discrepant labeling on the inner and outer packaging of the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0311-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-17
Posted: 2024-11-05
Recalling firm: Datascope Corp.
Product: MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: There is discrepant labeling on the inner and outer packaging of the device.
Root cause tag: labeling and UDI
FDA root 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 [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]
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.
Product codes and lots: UDI-DI: 10607567107974; Lot Number: 3000344298

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0311-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0311-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-05

Product code DSP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)