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Greatbatch Medical recalls Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The M
Recalled August 9, 2017 · FDA recall Z-2782-2017 · Greatbatch Medical
Hazard
One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed. · FDA Class II
Units
11,360
Sold at
CA
Description
One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
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.
Manufacturer(s)
Greatbatch Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →