Practical implication
Healthcare facilities must initiate the removal process for affected lots, isolate impacted products, and communicate the recall information to all relevant healthcare professionals. Compliance with the outlined return process is mandatory.
The recall affects specific lots of the Imager II Angiographic Catheter, which were found to have reduced concentrations and manufactured not in compliance with design specifications. The most common health risk is the detachment of the tip during intravascular use, potentially leading to delays in procedures. Healthcare establishments are required to inspect and return the affected products immediately.
What changed: Urgent device recall initiated for the Imager II Angiographic Catheter, with a deadline for return of confirmation forms to Boston Scientific set for September 18, 2026.
Why it matters: The recall addresses significant health risks associated with the device, ensuring patient safety and compliance with regulatory standards.
Practical implication: Healthcare facilities must initiate the removal process for affected lots, isolate impacted products, and communicate the recall information to all relevant healthcare professionals. Compliance with the outlined return process is mandatory.
View original source
- Source: ANSM (France) - Safety information feed
- Published at source: 2026-09-02T00:00:00.000Z
- Discovered by monitor: 2026-09-02T21:40:22.591Z
Published from the regulator source ingestion pipeline after PV impact triage.
