Recall Z-0852-2019 ยท DQX Wire, Guide, Catheter
Boston Scientific Corporation
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).
| Date | Dec 19, 2018 |
| Status | Terminated |
| Reason | A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires. |
| Root cause | Labeling mix-ups |
| 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. |
| Quantity | 49 units |
| Distribution | Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122795 | STINGRAY GUIDEWIRES Bridgepoint Medical, Nov 8, 2012 |