All Recalls

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

IV sets may leak.

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.

IV sets may leak.

The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in serious injuries or death to children. The dressers violate the mandatory standard required by the STURDY Act.

The baby loungers violate the mandatory standard for Infant Sleep Products because the sides are shorter than the minimum side height limit to secure the infant; the sleeping pad's thickness exceeds the maximum limit, posing a suffocation hazard; and the enclosed openings at the foot of the loungers are wider than allowed, posing fall and entrapment hazards to infants. The portable loungers do not have a stand, posing a fall hazard. These violations create an unsafe sleeping environment for infants, posing a risk of serious injury or death.

The screen console can overheat and ignite, posing a fire hazard.

The recalled PTV can leak fuel at the quick-connect fitting between the fuel line and the fuel injector mounted on the engine, posing a risk of serious injury and fire hazard.

The exhaust duct can crack, allowing gases to escape inside of the home, posing a carbon monoxide (CO) poisoning hazard that can result in death or serious injury.