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U.S. Department of Health and Human Services

Class 2 Device Recall MobiCath BiDirecctional Guiding Sheath.

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  Class 2 Device Recall MobiCath BiDirecctional Guiding Sheath. see related information
Date Initiated by Firm September 24, 2012
Date Posted October 24, 2012
Recall Status1 Terminated 3 on May 15, 2014
Recall Number Z-0132-2013
Recall Event ID 63316
510(K)Number K101784  
Product Classification Introducer, catheter - Product Code DYB
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Greatbatch Medical
2300 Berkshire Ln N
Minneapolis MN 55441-4575
For Additional Information Contact
763-951-8181
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 9040
Distribution Nationwide distribution: CA only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = Greatbatch Medical
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