Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | 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) |
| Quantity | 39 boxes of 5 (195 units) |
| Distribution | CA, FL, KY, MO, NM, OK, OR, PA, and TX. |
| Initiated | 2016-12-15 |
| Classified | 2017-06-30 |
| Terminated | 2018-04-10 |
| Recall number | Z-2645-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-2645-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76772/
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