Boston Scientific Recalls Imager II Angiographic Catheters
The company said catheter tips may fracture or detach, leaving fragments in patients or migrating through the vasculature.
Boston Scientific (BSX) recalled Imager II angiographic catheters in a voluntary Class I action the company initiated on Aug. 24, 2026.
The FDA reported the recall on Sept. 30, 2026, under number Z-3214-2026, and the agency’s center classified it on Sept. 23, 2026. The status is ongoing.
The recall covered 26 Imager II 5-French catheter configurations, including ST, BARNH, BERN, H1, SIM1, SIM2, SIM3, CHGB, CONTRA 2, C1, C2, MIK, SHK1.0, RC2 and RDC tip styles in 035 and 038 lengths.
Distribution was worldwide, including the United States, Puerto Rico and a long list of countries across Europe, Asia, the Americas, the Middle East and Africa. The basis was voluntary and firm-initiated.
The recall landed as Boston Scientific was still working through a cybersecurity incident it identified on Aug. 25, 2026, which disrupted manufacturing and order processing and which the company said was likely to have a material impact on third-quarter and full-year 2026 results. On Sept. 21, 2026, Arthur C. Butcher said he would retire as Executive Vice President and Group President, MedSurg and Asia Pacific, effective Jan. 1, 2027.
Boston Scientific had previously issued Class I recalls in Nov. 2024 on POLARx and POLARx FIT cryoablation balloon catheters to update instructions for use related to atrio-esophageal fistula risk.