Recall Z-0132-2013 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 | Oct 24, 2012 (initiated Sep 24, 2012) |
| Status | Terminated |
| Reason | We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths. |
| Root cause | Device Design |
| Action | The firm, Greatbatch, Ltd., sent an "URGENT CUSTOMER NOTIFICATION Medical Device - Voluntary Field Safety Notice" dated Monday, September 24, 2012 to its customer. The letter described the product, problem and actions to be taken. The customer was instructed to read the "Description of the Problem" and "Recommendations for Clinical Use" sections carefully; complete and return the attached Field Action Acknowledgement Form via mail to: Biosense Webster, Incl, 15715 Arrow Highway, Irwindale, CA 91706; Attn: Recall Coordinator, or Fax to: (909) 839-8514; pass on this notice to anyone in your fac |
| Quantity | 9040 |
| Distribution | Nationwide distribution: CA only. |
| 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 |