Greatbatch Medical: Medical Device Recall in 2017 - (Recall #: Z-2782-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 15, 2017

Date Posted: August 9, 2017

Recall Number: Z-2782-2017

Event ID: 76514

Reason for Recall:

One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.

Status: Terminated

Product Quantity: 11,360

Code Information:

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:

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated