Boston Scientific pulls Imager II catheters over tip-detachment risk

TL;DR Summary
Boston Scientific is discontinuing its Imager II Angiographic Catheters after a manufacturing issue could cause the catheter tip to detach; the FDA issued an early alert, two serious injuries have been reported, and healthcare facilities are instructed to stop using or distributing the devices and verify inventory using universal product numbers as the company removes the product from the market.
Topics:business#boston-scientific#fda-alert#healthcare#imager-ii-angiographic-catheters#manufacturing-issue#tip-detachment
- Boston Scientific discontinues angiographic catheters MedTech Dive
- Early Alert: Angiographic Catheter Issue from Boston Scientific fda.gov
- Boston Scientific removes imaging catheters from market due to risk of injury Cardiovascular Business
- ENROUTE Transcarotid Neuroprotection System Recalled Due to Potential for Tip Separation TCTMD.com
- Should Boston Scientific’s High‑Severity Device Recalls Reshape Risk Expectations for BSX Investors? simplywall.st
Reading Insights
Total Reads
1
Unique Readers
5
Time Saved
17 min
vs 18 min read
Condensed
98%
3,417 → 60 words
Want the full story? Read the original article
Read on MedTech Dive