Recall Z-0611-2013 ยท DYB Introducer, Catheter
Greatbatch Medical
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. T
| Date | Dec 22, 2012 (initiated Nov 12, 2012) |
| Status | Terminated |
| Reason | Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen). |
| Root cause | Nonconforming Material/Component |
| Action | Biosense Webster sent an "Urgent Field Safety Notice" dated November 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Voluntary Field Removal Certification Form was attached for customers to complete and return. Contact the firm at 800-729-9010 for questions related to this issue. |
| Quantity | 10,201 units |
| Distribution | Worldwide Distribution-USA including the states of AL, AK, AZ, ALR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KY, MD, MA, MI, MN, MO, NE, NV,NM, NJ, NH, NY, NC, OH, OK OR, PA, RI,SC,SD, TN, TX, UT,VT, VA, WA, and WI, and the countries of AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, SPAIN, FINLAND, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101784 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX Great Batch Medical, Nov 26, 2010 |