FDA-Device2017-07-12Class II
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
Hazard
A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
Sold states
CA, FL, KY, MO, NM, OK, OR, PA, and TX.
Affected count
39 boxes of 5 (195 units)
Manufactured in
2 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2645-2017More 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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