Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Biosense Webster MobiCath Bi-Directional Guiding Sheath Recalled by Greatbatch Medical Due to One side of the MobiCath Bi-Directional Guiding Sheath...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Greatbatch Medical directly.
Affected Products
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.
Quantity: 11,360
Why Was This Recalled?
One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
Where Was This Sold?
This product was distributed to 1 state: CA
About Greatbatch Medical
Greatbatch Medical has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report