FDA-Device2017-04-19Class II
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Hazard
One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters.
Sold states
AZ, FL, MO, NJ, NY, OH, PA, and TX.
Affected count
26 boxes of 5 (130 singles)
Manufactured in
2 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1781-2017More Boston Scientific Corporation recalls
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- FDA-Device2026-07-29Boston Scientific FARASTAR Ablation Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling
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