Recall Z-2224-2023— Datascope Corp.

Name: FDA recall Z-2224-2023
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: K002365. Product: REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr. D684-00-0403-05 REINFORCED INTRODUCER SET FOR SENSATION 7Fr. D684-00-0403-06 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr. D684-00-0403-10. 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

K002365 — DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SETDatascope Corp.·cleared 2000-08-25

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

REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr. D684-00-0403-05 REINFORCED INTRODUCER SET FOR SENSATION 7Fr. D684-00-0403-06 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr. D684-00-0403-10

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.