Primary source: What is an Early Alert?
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.
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.
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.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
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.
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