FDAJune 23, 2023device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
datascope
UPCs
1060756710936710607567109732106075671093741060756710974910607567113135106075671067791060756710955810607567109541106075671067551060756711312810607567106724
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABattery Charging Station; Model: 0998-00-0802;2026-02-06
- FDACS100 IABP. Software Version CS100 IABP Q.01.2026-01-23
- FDACS300 IABP. Software Version CS300 IABP C.01.2026-01-23
- FDACardiosave Rescue. Intra-Aortic Balloon Pump system.2025-11-04
- FDACardiosave Hybrid. Intra-Aortic Balloon Pump system.2025-11-04
- FDACardiosave Hybrid2025-10-23
- FDACardiosave Rescue2025-10-23
- FDAMEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-012024-09-17
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →