Z-1029-2016Class II

ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath...

Name: Z-1029-2016 ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath...
Creator: Argon Medical Devices, Inc
Published: 2016-02-17
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2016-02-17 / Terminated / root cause: manufacturing process

FDA source

Argon Medical Devices, Inc began a recall of 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... on 2016-02-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1029-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-17
Posted: 2016-03-01
Terminated: 2017-03-08
Recalling firm: Argon Medical Devices, Inc
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.
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1029-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1029-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-01

Product code DRE

K780126Class IIDilator, Vessel & Introducer, SheathArgon Medical Corp. / cleared 1978-03-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)