Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0132-2013 — 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

U.S. FDA — Device Enforcement · United States · 2012-09-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0132-2013
Date of alert: 2012-09-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Greatbatch Medical
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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