Pharmapedia Pro
Back to News
Recall25 Sept 2026Source: FDA Safety Alerts

Boston Scientific Imager II Angiographic Catheters Recalled

Boston Scientific has issued a recall for Imager II Angiographic Catheters due to a manufacturing issue involving reduced levels of stabilizing agents in the catheter tips. This defect can lead to tip degradation and detachment, potentially causing procedural delays or life-threatening embolisms obstructing blood flow.

The affected devices are used to image specific areas of the peripheral vasculature. The manufacturer has also decided to discontinue selling this product.

Healthcare facilities are advised to immediately stop using and distributing affected products, segregate them, verify inventory using UPN numbers, and return the items to Boston Scientific while completing the Reply Verification Tracking Form.

Key points

  • Recalled product: Imager II Angiographic Catheters by Boston Scientific.
  • Reason for recall: Reduced levels of stabilizing agents in catheter tips causing potential degradation and detachment.
  • Risks include procedural delays and life-threatening embolism leading to end organ failure.
  • Boston Scientific is discontinuing the sale of this product line.

What it means for you

Clinicians and proceduralists should immediately check their inventory for affected Imager II Angiographic Catheters and halt their use. Check with the Drug Regulatory Authority of Pakistan (DRAP) or local distributors regarding local product availability, guidance, and return procedures.

Read the original announcement

Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters

Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.