Recall Z-2782-2017 ยท DYB Introducer, Catheter
Greatbatch Medical
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 cathet
| Date | Feb 15, 2017 |
| Status | Terminated |
| Reason | One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed. |
| 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 1-763-95 |
| Quantity | 11,360 |
| Distribution | CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130559 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH Great Batch Medical, May 24, 2013 |