Recall Z-2069-2010 ยท DQX Wire, Guide, Catheter
Boston Scientific Corporation
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 200 cm x 10 cm, REF 50-811, UPN M001508110 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Valley City, UT 84119 USA.
| Date | Jul 22, 2010 (initiated Jun 3, 2010) |
| Status | Terminated |
| Reason | Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is coated with polytetrafluoroethylene (PTFE). Through internal inspection process, the firm determined that Fathom guidewires from affected lots may exhibit a P |
| Root cause | Process design |
| Action | Consignees were sent on 6/3/10 an "Urgent Medical Device Recall" letter dated 3 June 2010. The letter was addressed to Risk Manger/Interventional Radiology Manger/Material Manger. The letter described the problem and the product involved. The letter included the "Customer Instructions" which stated to Immediately discontinue use of an segregate recalled product and, requested customers to return the Reply Verification Tracking Form. Questions are directed to the firm at 510-624-2563. |
| Quantity | 164 units |
| Distribution | AL, AR, CA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MD, MA, MS, NV, NY, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT,VA, WA, WT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053268 | PVS 2000 SYNCHRO2 GUIDEWIRE Boston Scientific - Precision Vascular, Mar 13, 2006 |