FDAFDA · Alimentos y medicamentos·N.º oficial Z-2217-2023
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0469-01C SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0469-07 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0470-01C SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA) D684-00-0470-07 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0470-09 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES D684-00-0470-01 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0470-01U SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY D684-00-0469-01U SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES D684-00-0469-01 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY D684-00-0469-09 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs D884-00-0019-16
Publicado el 2 de agosto de 2023 · Inicio del retiro: 23 de junio de 2023
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- Datascope Corp.
- Distribuidor
- Domestic distribution nationwide. International distribution worldwide.
- Lote
- Product Description UDI SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) 10607567109367 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) 10607567109732 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA) 10607567109374 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA) 10607567109749 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113135 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES 10607567106779 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10607567109558 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY 10607567109541 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES 10607567106755 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY 10607567113128 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs 10607567106724
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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