FDA Device recall Z-2782-2017
Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve)
- FDA Device
- Class II
- terminated
- Published 2017-08-09
On 2017-08-09 the FDA classified a Class II recall of Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve) by Greatbatch Medical, citing one side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2782-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-15 |
| Published | 2017-08-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Greatbatch Medical |
| Distribution | CA |
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.
Reason
One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
Identifiers
| code_info | Model D140010, Lots: W3332609, W3338632, W3338635, W3338707, W3348350, W3348351, W3352503, W3359665, W3363850, W336385…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: |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2782-2017%22
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