medical Class II Updated 2023-08-02

Datascope Corp. recalls SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and

Recalled Product

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 PLUS 7.5Fr. 40cc WITH ACCESSORIES (WITH PRESSURE D684-00-0568-05 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (TURKEY) D684-00-0568-09 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES, US ONLY D684-00-0568-01U PACKAGED INSERTION KIT - SENSATION PLUS 7.5 Fr. 40 cc IAB D884-00-0019-22

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Description UDI SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES 10607567108063 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (W/O STATLOCK) 10607567109428 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (WITH PRESSURE 10607567109442 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (TURKEY) 10607567113166 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES, US ONLY 10607567109565 PACKAGED INSERTION KIT - SENSATION PLUS 7.5 Fr. 40 cc IAB 10607567108612
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