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U.S. Department of Health and Human Services

Class 2 Device Recall ClosureFast Micro Introducer Sheath Set

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  Class 2 Device Recall ClosureFast Micro Introducer Sheath Set see related information
Date Initiated by Firm February 17, 2016
Date Posted March 01, 2016
Recall Status1 Terminated 3 on March 08, 2017
Recall Number Z-1029-2016
Recall Event ID 73376
510(K)Number K780126  
Product Classification Dilator, vessel, for percutaneous catheterization - Product Code DRE
Product ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11.
Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Code Information Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)
Recalling Firm/
Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information Contact Rebecca Ellis
Manufacturer Reason
for Recall
The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.
FDA Determined
Cause 2
Process control
Action On February 17, a letter was sent to Medtronic notifying them of a voluntary recall.
Quantity in Commerce 2000 units
Distribution Distributed in IL.
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.
510(K) Database 510(K)s with Product Code = DRE and Original Applicant = ARGON MEDICAL CORP.