fda medwatch1 min read
saveBoston Scientific recalls Imager II angiographic catheters over tip detachment risk
read at fda medwatch ↗RegulatoryNegative
FDA's CDRH issued an Early Alert about Boston Scientific's Imager II angiographic catheters due to a manufacturing problem that can cause the catheter tip to detach.
The company sent a letter on August 24 advising customers to stop using or distributing the devices, to segregate any inventory, and to follow standard care for patients already treated.
Facilities are instructed to check both inner and outer packaging codes when locating the affected catheters and to complete the provided Reply Verification Tracking Form for reporting.
source
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Early Alert: Angiographic Catheter Issue from Boston Scientific”
read at fda medwatch ↗678 words · retrieved Aug 28
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