Recall Z-2222-2023
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
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES D684-00-0576-01 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-03 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-05 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0576-09 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0576-01U PACKAGED INSERTION KIT - SENSATION PLUS 8 Fr. 50 cc IAB D884-00-0019-23
Codes / lots: Product Description UDI SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES 10607567108605 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE 10607567109435 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE 10607567109381 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) 10607567113173 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY 10607567109633 PACKAGED INSERTION KIT - SENSATION PLUS 8 Fr. 50 cc IAB 10607567108599
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-2222-2023
- 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-2218-2023 Class II | TRANS-RAY 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-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-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 |