PV Bulletin

Early Alert: Angiographic Catheter Issue from Boston Scientific

Boston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism.

Primary source: What is an Early Alert?

PV Impact Brief

Urgency: HighConfidence: high

What changed

All health care facilities using Imager II Angiographic Catheters are now required to immediately stop further use or distribution of affected products as per Boston Scientific’s recommendation.

Why it matters

This action is crucial to prevent procedural delays and serious adverse health consequences, including the risk of embolism due to detachment of catheter tips during use.

Action needed

Health care professionals must complete and return the enclosed Reply Verification Tracking Form (RVTF) indicating the quantities of affected units to return, and monitor patients following the standard of care while discontinuing the use of these catheters.

Relevant for
Regulatory Intelligence LeadMedical Safety Lead
Processes impacted
Signal ManagementCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Aug 28, 2026

Full briefing

Practical implication

Health care professionals must complete and return the enclosed Reply Verification Tracking Form (RVTF) indicating the quantities of affected units to return, and monitor patients following the standard of care while discontinuing the use of these catheters.

The FDA has issued an Early Alert regarding the potential risks associated with the Boston Scientific Imager II Angiographic Catheters, which are being removed from usage due to manufacturing issues that may lead to serious health risks, including tip detachment.

What changed: All health care facilities using Imager II Angiographic Catheters are now required to immediately stop further use or distribution of affected products as per Boston Scientific’s recommendation.

Why it matters: This action is crucial to prevent procedural delays and serious adverse health consequences, including the risk of embolism due to detachment of catheter tips during use.

Practical implication: Health care professionals must complete and return the enclosed Reply Verification Tracking Form (RVTF) indicating the quantities of affected units to return, and monitor patients following the standard of care while discontinuing the use of these catheters.

View original source

  • Source: FDA - Medical Device Safety
  • Published at source: 2026-08-28T15:43:20.000Z
  • Discovered by monitor: 2026-08-29T05:45:08.926Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signal#Safety Signals#Source-ingestion#Regulator-monitor#Usa#Fda.gov

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