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. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum.
This recall has been terminated (originally issued October 24, 2012).
- Company
- Greatbatch Medical
- Recall Initiated
- September 24, 2012
- Posted
- October 24, 2012
- Terminated
- May 15, 2014
- Recall Number
- Z-0132-2013
- Quantity
- 9040
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide distribution: CA only.
Lot / Code Info
Lot no.: W2046680, W2046681, W2072907, W2078460, W2084872, W2098770, W2098771, W2102124, W2102128, W2102133, W2102134, W2108295, W2108296, W2108298, W2108299, W2108300, W2125688, W2125690, W2132584, W2132588, W2132590, W2138965, W2143146, W2143147, W2143149, W2143152, W2145645, W2145677, W2145680, W2145681, W2151287, W2151305, W2151308, W2156746, W2156748, W2156750, W2156751, W2162494, W2162496, W2162497, W2162498, W2162499, W2167985, W2167986, W2167987, W2167988, W2167990, W2172705, W2172706, W2172707, W2172708, W2172710, W2172712, W2177727, W2177728, W2177729, W2177730, W2177733, W2177734, W2184476, W2184483, W2184484, W2184485, W2184487, W2184489, W2190457, W2190461, W2190462, W2190464, W2190470, W2196349, W2196351, W2196352, W2196355, W2196359, W2196361, W2196363, W2211842, W2211844, W2211846, W2211849, W2211850, W2211851, W2211852, W2211853, W2213887, W2213890, W2213892, W2213896, W2213898, W2213901, W2213982, W2221631, W2222017, W2222020, W2222022, W2222024, W2222027, W2222030, W2224408, W2224412, W2224417, W2224421, W2224423, W2224433, W2229959, W2229960, W2229961, W2229963, W2229965, W2229973, W2229974, W2236558, W2236561, W2236588.
Root Cause
Device Design
Action Taken
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 facility that needs to be informed; maintain awareness of this communication until information has been incorporated into the device labeling, and to avoid the catheter inside the MobiCath Bi-Directional Guiding Sheath from "self-advancing", physicians should reposition the catheter handle when manipulating the catheter in and out of the sheath. Greatbatch, Ltd. is updating the MobiCath Bi-Directional Guiding Sheath Instructions For Use (IFU) accordingly. Supplemental information will be provided with future shipments of these devices, until the revised IFU is available. For questions related to the issue please contact your Biosense Webster representative or call (800) 729-9010, Monday through Friday from 9:00 AM to 6:00 PM EST. For questions related to the Acknowledgment Form and its return, please contact Field Action Coordinator at (909) 839-8468.