People's Justice
The Wire · All news

Birth Injury

FDA Issues Class I Recall for Abiomed Impella CP Set Over Blood Clot Risk

Published Updated

By People's Justice

What happened

The FDA issued a Class I recall for the Abiomed Impella CP Set with SmartAssist (10th Generation), citing a potential for thrombus (blood clot) formation during prolonged use of the included 14Fr Low Profile Introducer Kits. A Class I recall is the most serious category, reserved for situations where use of a device may cause serious injury or death.

Event date:

Source: api.fda.gov

Birth Injury case guideCheck eligibility

Related news

  1. Birth Injury

    CPSC Recalls VEVOR Baby Loungers and AMASKY Nursing Pillows Over Infant Injury and Death Risks

    On July 2, 2026, the U.S. Consumer Product Safety Commission issued two separate recalls affecting infant sleep and feeding products. VEVOR baby loungers were recalled due to entrapment and fall hazards and for violating mandatory infant sleep product standards. AMASKY nursing pillows, sold on Amazon by Pretty-Life, were recalled due to suffocation risk and for violating mandatory standards for nursing pillows and infant support cushions.

    Source: cpsc.gov

  2. Birth Injury

    CPSC Recalls VEVOR Baby Loungers Over Entrapment and Fall Hazards

    On July 2, 2026, the U.S. Consumer Product Safety Commission issued Recall No. 26-591 for VEVOR baby loungers, citing risks of serious injury or death from entrapment and fall hazards. The CPSC stated the products violate the mandatory federal standard for infant sleep products. Recalled units were sold in multiple colors and prints, including snow deer, good night, forest friends (oval), forest friends (backpack), and green.

    Source: cpsc.gov

  3. Birth Injury

    FDA Issues Class I Recall for Abiomed Impella CP Over Clot Risk

    The FDA issued a Class I recall for the Abiomed Impella CP Set with SmartAssist (10th Generation), citing the potential for thrombus (blood clot) formation during prolonged use of the affected 14Fr Low Profile Introducer Kits. A Class I recall is the FDA's most serious category, indicating a reasonable probability that use of the device could cause serious injury or death.

    Source: api.fda.gov