FDA-Device2019-02-27Class II
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).
Boston Scientific Corporation
Hazard
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Sold states
Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY.
Affected count
49 units
Manufactured in
1 Scimed Pl, Maple Grove, MN, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0852-2019Don't want to check this manually?
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