Alerta De Seguridad para MOBICATH Bi-Directional Guiding Sheath

Safety alert

2012-11-19

2012-11-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121119.html

Medical device safety alert: greatbatch mobicath bi-directional guiding sheath medical device manufacturer, greatbatch ltd., inc., has initiated a voluntary product removal concerning mobicath bi-directional guiding sheath small curve (catalogue no.: d0140010) and mobicath bi-directional guiding sheath large curve (catalogue no.: d0140011). the manufacturer has recently observed some anomalies of the inner lumen of the mobicath sheath during the implementation of a new inspection tool during visual inspection. the anomalies may include loose, string-like liner material, line abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen). to date, there have been no patient injuries, or adverse events reported as a result of this issue and there have been no reported complaints of this type of defect. however, under the worst case scenario, a loose piece of the liner could be introduced into a patient during a procedure and potentially lead to a patient embolic event. for this reason, the manufacturer and the distributor decided to voluntarily recall all lots of the mobicath bi-directional guiding sheath small curve (d140010) and mobicath bi-directional guiding sheath large curve (d140011). according to the local supplier, johnson & johnson (hong kong) ltd., the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 november 2012.