FDAFebruary 10, 2016device
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventri...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
What to do
FDA enforcement status: Terminated
Brands named
arrow international inc divisionarrowarrow international
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCFlaunt Recalls Magsafe Battery Chargers Due to Risk of Serious Injury or Death from Fire and Burn Hazards2026-07-09
- CPSCArizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by 7111495 Canada2026-06-18
- CPSCSUNS International Recalls Residential Elevator Interlock Switches Due to Fall and Crushing Hazard; Risk of Death or Serious Injury2026-06-04
- CPSCMiniWarGaming and Primal Horizon Disc Magnets Recalled Due to Risk of Serious Injury or Death from Ingestion; Violate Mandatory Standard for Magnets; Imported by MiniWarGaming2026-05-28
- CPSCMissry Associates Recalls Misco Sports Light-Up Racket Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys2026-05-28
- FDAMedtronic O-arm O2 Imaging System. Model Number: BI70002000.2026-05-19
- FDADairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box2026-05-18
- FDADairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags2026-05-18
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 →