FDA Medical Device Recalls (openFDA)
Datascope Corp.: TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES D684-00-0546-01 TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES D684-00-0607 TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES D684-00-0608 PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs D884-00-0019-18 PACKAGED INSERTION KIT - TRANS-RAY PLUS 7.5 Fr. 35/40 IABs D884-00-0019-26
- Recall number
- Z-2218-2023
- Recalling firm
- Datascope Corp.
- Product
- TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES D684-00-0546-01 TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES D684-00-0607 TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES D684-00-0608 PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs D884-00-0019-18 PACKAGED INSERTION KIT - TRANS-RAY PLUS 7.5 Fr. 35/40 IABs D884-00-0019-26
- Status
- Open, Classified
- Initiated
- 2023-06-23
- Posted
- 2023-07-21
- Terminated
- not on file
- Reason
- During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
- Root cause
- Under Investigation by firm
- Action
- Firm notified customers on June 23, 2023 via letter. Customers were made aware of the potential for the device to break during use and the risk of using the device. Customers were given alternate solutions to continue using the IAB Catheter with alternative sheath/dilator combinations. Customers may also return their affected product for a credit. The firm will continue to ship product to customers who choose to continue receiving it. However, product currently being shipped is potentially affected by the same issue. Datascope/Getinge has identified the issue with the introducer dilator and is working with the supplier towards a resolution. If you have any questions, please contact your Datascope/Getinge representative or call Datascope/Getinge Customer Service at 1-888-943-8872, options 2, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
- Quantity
- 321,609 total kits
- Distribution
- Domestic distribution nationwide. International distribution worldwide.
- Lot, serial or model codes
- Product Description UDI 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES 10607567107656 TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES 10607567107663 TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES 10607567111711 TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES 10607567111728 PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs 10607567107684 PACKAGED INSERTION KIT - TRANS-RAY PLUS 7.5 Fr. 35/40 IABs 10607567111810
- 510(k) numbers
- not on file
- 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