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 batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires. |
| Product | Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). |
| Quantity | 49 units |
| Distribution | Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY. |
| Initiated | 2018-12-19 |
| Classified | 2019-02-20 |
| Terminated | 2020-06-09 |
| Recall number | Z-0852-2019 |
| 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-0852-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81863/
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