ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7… recallZ-1029-2016 · Argon Medical Devices, Inc · initiated Feb 17, 2016
Class II Terminated All recalls posted in March 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Argon Medical Devices, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
On February 17, a letter was sent to Medtronic notifying them of a voluntary recall.
Recall details
- Recall number
- Z-1029-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 17, 2016
- Posted by the FDA
- Mar 1, 2016
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 2000 units
- Product code
- DRE
- FDA submissions
- K780126
- Distribution
- Distributed in IL.
Product description
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 (models, lots, serial numbers)
Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)
Other devices under the same FDA submission
16 devices cleared under K780126 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- One-Piece Introducer Tray 497434Argon Medical Devices, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- One-Piece/Tuohy-Borst Introducer Tray 497455Argon Medical Devices, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- ClosureFast MIS-7F07Covidien LP · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION23 reports
- ClosureFast Micro Introducer Sheath MIS-7F07Argon Medical Devices, Inc. · Dilator, Vessel, For Percutaneous Catheterization12 reports
- Catheter Introducer Kit 6F 497792*Argon Medical Devices, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 reports
- OneStic Micro-Access Introducer 497847Argon Medical Devices, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 reports
- Axcess Percutaneous Introducer 191745Argon Medical Devices, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 report
- One Piece/Tuohy-Borst Catheter Introducer 496132Argon Medical Devices, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 report
- PAC Tray/5 Catheter Introducer Tray 497424Argon Medical Devices, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 report
- PCI Kit/4 Percutaneous Catheter Introducer A496162Argon Medical Devices, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 report
- OneStic Micro-Access Introducer 497862Argon Medical Devices, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 report
- OneStic Micro-Access Introducer 497830Argon Medical Devices, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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