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. Small Curve catalog no. Recalled by Greatbatch Medical Due to We are notifying you of a potential interaction...
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. 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.
Quantity: 9040
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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