Z-1685-2022Class II

MEGA 8Fr 50cc Intra-Aortic Balloon Catheter

Name: Z-1685-2022 MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Creator: Datascope Corporation
Published: 2022-08-05
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2022-08-05 / Open, Classified / root cause: supplier

FDA source

Datascope Corporation began a recall of MEGA 8Fr 50cc Intra-Aortic Balloon Catheter on 2022-08-05. FDA classified it as Class II and gives the reason as "Certain lots containing undersized dilator". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1685-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-05
Posted: 2022-09-08
Recalling firm: Datascope Corp.
Product: MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Certain lots containing undersized dilator.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: The firm distributed an Urgent Medical Device Removal notification, by mail, dated August 5, 2022. The notification informs customers that certain lots of 8Fr. 50cc IAB catheter and insertion kits are being recalled due to an undersized vessel dilator. During a sheathless insertion, the undersized inner diameter may result in the inability to insert the guidewire through the inner lumen of the dilator and the undersized outer diameter may reduce dilation of the vessel. If used in a procedure, recalled product could result in a procedural delay, gas emoli, and vessel injury. Customers are asked to examine their inventory to determine if they have nay recalled product and to quarantine any affected units. Customers with recalled product are to contact Datascope Corp./Getinge Customer Service at 888-9GETUSA (888-943-8872, option 2) between the hours of 8 AM and 6 PM to request a return authorization number to receive full credit. Distributors who have shipped any product are to forward the notification to customers. The recall notification is to be forwarded to all users at hospitals/facilities. Customers are asked to complete and return the recall response form by email to [email protected] or by fax to 877-647-1921.
Quantity in commerce: 10,427 units
Distribution: Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Product codes and lots: Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567109619, 3000184437, 0684-00-0296-01U; 10607567107301, 3000171501, 0684-00-0498-01; 10607567107301, 3000183312, 0684-00-0498-01; 10607567107301, 3000183313, 0684-00-0498-01; 10607567107301, 3000186654, 0684-00-0498-01; 10607567107301, 3000186655, 0684-00-0498-01.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1685-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1685-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1686-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1687-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08

Product code DSP

K133074Class IIMega 8Fr. 50Cc and Sensation Plus 8Fr. 50Cc Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp. / cleared 2013-12-12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)