Recalls / —
—#170155
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).
- FDA product code
- DQX — Wire, Guide, Catheter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K122795
- Affected lot / code info
- Material Number (UPN) H749M3004A0, Batch Number 21558994, Expiration Date 11/30/2019
Why it was recalled
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
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.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 1 Scimed Pl, Maple Grove, Minnesota 55311-1565
Distribution
- 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.
Timeline
- Recall initiated
- 2018-12-19
- Terminated
- 2020-06-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #170155. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.