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Greatbatch Medical recalls Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D1400
Recalled October 31, 2012 · FDA recall Z-0132-2013 · Greatbatch Medical
Hazard
We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths. · FDA Class II
Units
9040
Sold at
Nationwide distribution: CA only.
Description
We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths.
Product
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. 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 MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum.
Manufacturer(s)
Greatbatch Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →