In its notice, the FDA said the early alert notifies the public of a potentially high-risk device. It said Abiomed sent a letter to affected customers recommending the removal of all 14Fr low-profile introducer kits from use and sale. Affected devices include the 14Fr x 13 cm kit, the 14Fr x 25 cm kit and the Impella CP set with SmartAssist (10th generation). These devices facilitate access to the vascular system for the introduction and removal of Impella CP with SmartAssist and ancillary devices. The recall does not involve any other generation of Impella CP that is commercially available. Affected kits are available at six hospitals in the U.S.
According to the FDA, Abiomed identified a higher rate of complaints than expected related to thrombus formation with the kits during prolonged use of the introducer. If thrombus formation occurs, the user may have difficulty aspirating the sheath sidearm or valve. The user may also observe thrombus in the syringe or sidearm post-aspiration or around the valve following CP pump removal.
Thrombus formation within the indwelling sheath lumen or annular gap between the sheath inner diameter and the catheter outer diameter during prolonged support may result in disruption of blood flow near the access site. Dislodged thrombus may result in peripheral vessel obstruction with ischemia. This requires prompt clinical assessment and intervention to restore perfusion. In some cases, if not corrected, exposure could progress to irreversible vascular occlusion with potential for permanent impairment.
As of May 15, Abiomed reports three serious injuries and no deaths associated with the issue.
Statement from J&J
A Johnson & Johnson spokesperson shared the following statement with MassDevice via email:
“Johnson & Johnson is initiating a voluntary recall (removal) of the 14Fr Low Profile Introducer kits after identifying an increased risk of thrombus formation, available at six hospitals in the U.S.
“The 14Fr Low Profile Introducer Kit, which facilitates access to the vascular system, is only compatible with the Impella CP 10th generation, which is only available with the 14Fr Low Profile Introducer kits.
“Patient safety is our top priority, and we are working with the six impacted hospitals in the U.S. to return the product and issue credits.”
Another warning for J&J, Abiomed and Impella
Abiomed, which J&J acquired for $16.6 billion in 2022, has faced a handful of regulatory issues related to the Impella platform in recent years.
Last fall, Abiomed reported five serious injuries and no deaths associated with an issue with AIC purge pressure, leading to purge retainer failures, such as cracks. That warning came not long after different FDA communications related to the Impella pump controllers. In July 2025, the FDA alerted providers that Abiomed issued updated instructions for use related to all of its AICs. As of June 13, Abiomed had reported no serious injuries and 3 deaths associated with that issue.
In August 2025, the FDA issued another alert for Abiomed instructing customers to remove certain AICs from use or sale. According to an Abiomed spokesperson, the issue affected 69 AICs globally. As of Aug. 12, 2025, Abiomed reported one death and no serious injuries associated with that issue.
In February, the FDA said Abiomed issued an urgent medical device correction to notify affected customers of updated use instructions for all Impella RP with Smart Assist and Impella RP Flex with Smart Assist devices. Later that month, it issued a warning related to Impella purge cassettes.
Then, last month, the company initiated a voluntary recall for Impella AICs after identifying a potential software issue in a limited number of AICs when used with left ventricular Impella devices. It then issued a warning recommending the removal of certain Impella CP sets with SmartAssist that failed to meet design specifications.
