Recall Z-2218-2023
Datascope Corp. · initiated June 23, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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).
Details
- Recall number
- Z-2218-2023
- Initiated
- June 23, 2023
- Posted by FDA
- July 21, 2023
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- Quantity
- 321,609 total kits
- Distribution
- Domestic distribution nationwide. International distribution worldwide.
- Recalling firm
- Datascope Corp., Fairfield, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2216-2023 Class II | YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2217-2023 Class II | SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2219-2023 Class II | MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2220-2023 Class II | MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2221-2023 Class II | SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2222-2023 Class II | SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2223-2023 Class II | LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2224-2023 Class II | REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |