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).
FDA Recall Z-0852-2019 · Posted None
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQX
Date Initiated2018-12-19
Date Terminated2020-06-09
Product Quantity49 units
Reason for Recall
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Firm Action
Boston Scientific notified customers on about 12/19/2018 via "Urgent Medical Device Removal - Immediate Action Required" notice. Instructions included to immediately discontinue use of and segregate affected product, complete and return the Reply Verification Tracking Form to receive a RGA to return affected product, return all affected product, notify customers of the recall if product was further distributed.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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