Recall Z-2220-2023— Datascope Corp.

Name: FDA recall Z-2220-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-23

Class II · Ongoing

Class II FDA medical device recall by Datascope Corp., initiated 2023-06-23. It names one FDA 510(k) clearance: K133074. Product: MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D684-00-0296-01 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA D684-00-0296-02 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0296-03 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0296-09 MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0296-10 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0296-01U MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0296-02U MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) D684-00-0498-01 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) D684-00-0498-07 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0498-08 PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB D884-00-0019-17. 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..

Recalling firm: Datascope Corp.
Classification: Class II
Status: Ongoing
Initiated: 2023-06-23
Firm location: Fairfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIESDatascope Corp.·cleared 2013-12-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D684-00-0296-01 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA D684-00-0296-02 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0296-03 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0296-09 MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0296-10 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0296-01U MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0296-02U MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) D684-00-0498-01 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) D684-00-0498-07 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0498-08 PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB D884-00-0019-17

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.