FDA Device recall Z-0852-2019
Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices duri…
- FDA Device
- Class II
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices duri… by Boston Scientific, citing A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0852-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-19 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
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
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Identifiers
| code_info | Material Number (UPN) H749M3004A0, Batch Number 21558994, Expiration Date 11/30/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0852-2019%22
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