Boston Scientific Discontinues Imager II Catheters After Tip Defect Recall

Key points

• Boston Scientific issued a recall letter on August 24, 2026, instructing customers to immediately stop using and return all Imager II Angiographic Catheters.
• The FDA upgraded the alert to a Class I recall on September 25, 2026, designating it as the most serious type due to the risk of serious injury or death.
• The defect involves reduced levels of stabilizing agents in the catheter tips, which may cause degradation or detachment during use.
• As of July 16, 2026, Boston Scientific reported two serious injuries and no deaths associated with the issue, though no increase in complaints was identified for the affected lots.
• The company has decided to discontinue the product entirely, stating it will no longer be available for procedures after the removal process is complete.

Background

This recall follows a period of operational instability for Boston Scientific. In late August 2026, the company disclosed a cyberattack that disrupted global IT systems and shipment services, causing stock declines and operational delays. Additionally, in July 2026, Boston Scientific announced a restructuring plan involving up to $800 million in charges to streamline its supply chain. Earlier this year, the company also recalled a different catheter used in stroke prevention systems acquired from Silk Road Medical due to similar tip separation risks.

How outlets are covering it

MedTech Dive and the FDA emphasize the permanent discontinuation of the Imager II line, highlighting that the devices were manufactured outside of approved design specifications despite no spike in complaints. Cardiovascular Business notes that the initial FDA warning was part of an Early Alert pilot program, focusing on the immediate need for clinicians to verify inventory using both inner and outer packaging codes. TCTMD.com provides context on a separate but related recall of the ENROUTE Transcarotid Neuroprotection System, which also involved tip separation issues and was upgraded to a Class I recall, suggesting a broader pattern of manufacturing concerns in Boston Scientific's catheter portfolio.

Why it matters

The discontinuation of a widely used diagnostic tool impacts interventional cardiologists, vascular surgeons, and radiologists who rely on these catheters for peripheral vasculature imaging. The Class I classification signals a high risk of harm, potentially affecting patient safety and procedural efficiency. For Boston Scientific, this adds to a challenging period involving cyberattacks and restructuring, potentially impacting its reputation and financial stability in the medical device sector.

What to watch

Healthcare facilities must continue to verify their inventory using universal product numbers (UPNs) for both inner and outer packaging to ensure all affected units are returned. Boston Scientific will process returns and handle the logistics of removing the product from the market. The FDA will monitor the recall's effectiveness and any further adverse event reports. The company may face increased scrutiny on its manufacturing quality control processes, especially given recent cyber and restructuring issues.