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.
This recall has been terminated (originally issued February 15, 2017).
- Company
- Greatbatch Medical
- Recall Initiated
- February 15, 2017
- Terminated
- May 9, 2019
- Recall Number
- Z-2782-2017
- Quantity
- 11,360
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
Reason for Recall
One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
Distribution
CA
Lot / Code Info
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:
Root Cause
Process control
Action Taken
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 FieldActionCenter@Greatbatch.com