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U.S. Department of Health and Human Services

Class 2 Device Recall StarClose SE Vascular Closure System

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  Class 2 Device Recall StarClose SE Vascular Closure System see related information
Date Initiated by Firm February 10, 2017
Create Date February 15, 2017
Recall Status1 Terminated 3 on December 06, 2017
Recall Number Z-1202-2017
Recall Event ID 76448
PMA Number P050007 
Product Classification Device, hemostasis, vascular - Product Code MGB
Product StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02.

The UDI is 08717648079467.
The GMDN is 47411.
Code Information Part No. 14679-01 50908K1 50916K1 51013K1 51021K1 51106K1 5101241 5101441 5101941 5102141 5102741 5103141 5110541 5111041 5121041 5121541 5121741 5122341 6012641 6012941 6020341 6020841 6021141 6021641 6021841 6022541 6022941 6030341 6030841 6041241  Part No. 14679-02 50831K1 50903K1 50911K1 50921K1 50924K1 50929K1 51002K1 51008K1 51016K1 51026K1 51029K1 51103K1 5111741 5112041 5112441 5112741 5120141 5120441 6010641 6011141 6011441 6011941 6012241 6031041 6031541 6032241 6032941 6041941 6042141 6042641 6042941 6051141 6051341 6051941 6052441 6061541 6100341 
Recalling Firm/
Manufacturer		 Abbott Vascular
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact
951-914-2400
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 170,008 units total (83,029 units in US)
Distribution US: Germany, Italy, Puerto Rico, Spain, Sweden, Switzerland,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MGB and Original Applicant = ABBOTT VASCULAR DEVICES
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