FDA issues early alerts on multiple high-risk device recalls from J&J, Medtronic, Baxter, Boston Scientific

Editor's Note

The Food and Drug Administration (FDA) has issued a series of early alerts this month regarding high-risk recalls from several leading medical device makers, citing patient safety risks ranging from pump failures to vascular complications. These alerts highlight issues with products from Johnson & Johnson’s (J&J’s) Abiomed unit, Medtronic, Baxter, and Boston Scientific.

According to an August 27 article from Modern Healthcare, J&J’s Abiomed has recalled its Automated Impella Controllers, which serve as the user interface for its catheter-based heart pumps. The FDA alert followed reports of one death tied to a lower-rated electrical component that could cause the pump to underperform or stop. The devices, acquired through J&J’s $16.6 billion Abiomed purchase in 2022, are designed to reduce the workload of the left ventricle in heart failure patients. Abiomed reported $360 million in sales in the second quarter of 2025.

Separately, an August 15 FDA communication reports that Medtronic recalled specific models of its DLP Left Heart Vent Catheters after identifying some failed to maintain shape when bent. This defect can cause abrasion or perforation of heart tissue if not recognized before use. As of late July, Medtronic had received reports of three serious injuries but no deaths. Affected lots must be quarantined and returned, and the company has warned of limited product availability in coming months.

The FDA also flagged an urgent correction for Baxter’s Novum IQ infusion pumps, covering both large volume and syringe models. According to the August 15 recall notice, software anomalies may cause blank Run screens or false motor movement errors, risking therapy interruptions. While blank screens do not immediately halt infusions, users cannot adjust therapy without restarting the device, potentially leading to under- or over-infusion. Baxter has received three reports of serious injuries and no deaths to date. Customers are advised to consider alternate pumps for high-risk patients and follow detailed correction steps if continued use is necessary.

Finally, the FDA announced on August 22 that Boston Scientific is recalling certain lots of its Carotid WALLSTENT Monorail Endoprosthesis due to manufacturing defects that narrowed the device lumen, causing resistance during withdrawal. This flaw can damage vessels, compromise the stent, or dislodge debris that could result in stroke. Boston Scientific reported six cases requiring additional interventions but no deaths as of late July. Affected stents must be immediately removed from inventory and returned to the company.