FDA Medical Device Recalls (openFDA)
Datascope Corporation: MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
- Recall number
- Z-1685-2022
- Recalling firm
- Datascope Corporation
- Product
- MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
- Status
- Open, Classified
- Initiated
- 2022-08-05
- Posted
- 2022-09-08
- Terminated
- not on file
- Reason
- Certain lots containing undersized dilator.
- 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 Dilator8Fr2022@getinge.com or by fax to 877-647-1921.
- Quantity
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K133074"]
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 1000222374
- Firm city
- Fairfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28