Z-2782-2017Class II

Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large...

Name: Z-2782-2017 Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large...
Creator: Greatbatch Medical
Published: 2017-02-15
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2017-02-15 / Terminated / root cause: manufacturing process

FDA source

Greatbatch Medical began a recall of Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a... on 2017-02-15. FDA classified it as Class II and gives the reason as "One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2782-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-15
Posted: 2017-07-29
Terminated: 2019-05-09
Recalling firm: Greatbatch Medical
Product: Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). 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 kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.
Product code: DYB Introducer, Catheter
Reason for recall: One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignee was sent a Greatbatch "Urgent Medical Device Recall" letter dated February 15, 2017 via UPS and email . The letter was addressed to Biosense Webster, Inc. The letter described the product involved in the recall, Reason for Recall, Risk to Health,& Instructions to Biosense Webster. Advised consignee to quarantine and return the devices, complete and return the field Recall Response Form to Stericycle, and to communicate the recall to their customers and end users. For questions contact your local Greatbatch Medical representative, Monday through Friday via telephone at 1-763-951-8184 from 8:00 AM (CST) to 5:00 PM (CST), or e-mail us at [email protected]
Quantity in commerce: 11,360
Distribution: CA
Product codes and lots: Model D140010, Lots: W3332609, W3338632, W3338635, W3338707, W3348350, W3348351, W3352503, W3359665, W3363850, W3363851, W3370052, W3374699, W3374700, W3379647, W3379650, W3384700, W3384701, W3390549, W3390551, W3397877, W3397879, W3397950, W3407814, W3407815, W3436351, W3436355, W3436356, W3436358, W3441735, W3441737, W3446767, W3446769, W3449392, W3451862, W3451863, W3455438, W3455439, W3455440, W3459354, W3462467, W3462470, W3470335, W3470336, W3483637, W3493240, W3497507, W3501348, W3501349, W3581648, X3489776, X3497121, X3497510, X3501344, X3501345, X3503248, X3507599, X3514814, X3518116, X3565743, X3581652, X3586059, X3592497. Model D140011, Lots:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2782-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2782-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29

Product code DYB

K130559Class IIMobicath Bi-Directional Guiding SheathGreat Batch Medical / cleared 2013-05-24

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)