Z-0132-2013Class II

Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog...

Name: Z-0132-2013 Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog...
Creator: Greatbatch Medical
Published: 2012-09-24
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2012-09-24 / Terminated / root cause: design

FDA source

Greatbatch Medical began a recall of Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding... on 2012-09-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0132-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-24
Posted: 2012-10-24
Terminated: 2014-05-15
Recalling firm: Greatbatch Medical
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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: design
FDA 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 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0132-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0132-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-24

Product code DYB

K101784Class IIMobicath Bi-Directional Guiding Sheath Model 1000182-XxxGreat Batch Medical / cleared 2010-11-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)