Z-0132-2013 Class II Terminated
FDA device recall Z-0132-2013 was initiated by Greatbatch Medical on September 24, 2012 and is designated Class II. 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 … The recall status is terminated (terminated May 15, 2014). Affected quantity: 9040.
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2012
- Initiation Date
- September 24, 2012
- Termination Date
- May 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9040
Product Description
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.
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 Pattern
Nationwide distribution: CA only.
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.