Datascope Corp.: REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER

Hazard

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.

Details from the source

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: Domestic distribution nationwide. International distribution worldwide. Quantity: 321,609 total kits Lot/code info: Product Description UDI REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr. 10607567106656 REINFORCED INTRODUCER SET FOR SENSATION 7Fr. 10607567106694 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr. 10607567107943

UPC codes

10607567106656, 10607567106694, 10607567107943

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.