Stingray" Guidewire — Class II medical device recall Z-0852-2019
Terminated recall by Boston Scientific Corporation, reported 2019-02-27, distributed nationwide. A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
| Recall number | Z-0852-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2018-12-19 |
| Classified | 2019-02-20 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2020-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 49 units |
| Reason classes | labeling |
| Lot numbers | 21558994 |
| Expiration dates | 2019-11-30 |
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).
Reason for recall
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0852-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.