Home / Recalls / Datascope Corp. / Z-2220-2023

Z-2220-2023 Class II Ongoing

Recalled by Datascope Corp. — Fairfield, NJ

Recall Details

Product Type
Devices
Report Date
August 2, 2023
Initiation Date
June 23, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
321,609 total kits

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.

Distribution Pattern

Domestic distribution nationwide. International distribution worldwide.

Code Information

Product Description UDI MEGA 8Fr. 50cc IAB WITH STATLOCK 10607567108001 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA 10607567108018 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) 10607567109411 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) 10607567113265 MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113272 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY 10607567109619 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY 10607567109626 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) 10607567107301 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) 10607567109756 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) 10607567109763 PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB 10607567107493

Other recalls by Datascope Corp.

  • Z-1587-2026 Class III — Battery Charging Station; Model: 0998-00-0802; (February 6, 2026)
  • Z-1487-2026 Class II — CS300 IABP. Software Version CS300 IABP C.01. (January 23, 2026)
  • Z-1486-2026 Class II — CS100 IABP. Software Version CS100 IABP Q.01. (January 23, 2026)
  • Z-0916-2026 Class II — Cardiosave Hybrid. Intra-Aortic Balloon Pump system. (November 4, 2025)
  • Z-0917-2026 Class II — Cardiosave Rescue. Intra-Aortic Balloon Pump system. (November 4, 2025)
  • Z-0931-2026 Class III — Cardiosave Hybrid (October 23, 2025)
  • Z-0932-2026 Class III — Cardiosave Rescue (October 23, 2025)
  • Z-0311-2025 Class II — MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0 (September 17, 2024)
  • Z-3134-2024 Class I — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use (August 8, 2024)
  • Z-3136-2024 Class I — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use (August 8, 2024)