Recall Z-2221-2023 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES D684-00-0568-01 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (W/O STATLOCK) D684-00-0568-03 SENSATION PLU
| Date | Jul 21, 2023 (initiated Jun 23, 2023) |
| Status | Open, Classified |
| 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 |
| Quantity | 321,609 total kits |
| Distribution | Domestic distribution nationwide. International distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122628 | SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES Datascope Corp., Cardiac Assist Division, Sep 6, 2012 |