Z-1202-2017Class II

StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is...

Name: Z-1202-2017 StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is...
Creator: Abbott Vascular
Published: 2017-02-10
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2017-02-10 / Terminated

FDA source

Abbott Vascular began a recall of StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411 on 2017-02-10. FDA classified it as Class II and gives the reason as "Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1202-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-10
Posted: 2017-02-15
Terminated: 2017-12-06
Recalling firm: Abbott Vascular
Product: StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
Product code: MGB Device, Hemostasis, Vascular
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 root cause: 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,
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1202-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1202-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-15

Product code MGB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)