FDA Enforcement Class II Ongoing

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

Recall: Z-2222-2023 · Reported August 2, 2023

Enforcement

Recall Number: Z-2222-2023
Event ID: 92527
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: Datascope Corp.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: N/A
Report Date: August 2, 2023
Initiation Date: June 23, 2023
Classification Date: July 21, 2023
Address: 15 Law Dr Unit 1, N/A, Fairfield, NJ, 07004-3206, United States

Description

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.

Code Info

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

Distribution

Domestic distribution nationwide. International distribution worldwide.

Quantity

321,609 total kits