StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
FDA Recall Z-1202-2017 · Posted None
Recalling FirmAbbott Vascular
Recall StatusTerminated
Product CodeMGB
Date Initiated2017-02-10
Date Terminated2017-12-06
Product Quantity170,008 units total (83,029 units in US)
Reason for Recall
Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.
Firm Action
An urgent field safety notice will be sent to customers on 2/10/17 to inform them that Abbott Vascular has initiated a recall regarding specific lots of the StarClose SE Vascular Closure System. Customers are informed that product from the identified lots may exhibit difficulty or failure to deploy the StarClose SE Clip. Potential risks associated with this event include prolonged procedure times, use of another device or manual compression to achieve hemostasis. Customers are instructed of the actions to be taken and what Abbott Vascular is doing about the recall. Customers with any questions are instructed to contact their local Abbott Vascular Representative or Customer Service Department at (800) 227-9902.
Root Cause
Other
Distribution Pattern
US: Germany, Italy, Puerto Rico, Spain, Sweden, Switzerland,
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.