Percutaneous Catheter Introducer Set, VNUS Medical… recallZ-0764-2010 · Argon Medical Devices, Inc · initiated Jan 6, 2009
Terminated All recalls posted in February 2010
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
One lot of Percutaneous Catheter Introducer Set contained incorrect size needle.
FDA root cause category: Other
What the company is doing
Firm notified sole consignee by an Urgent Medical Device Recall certified letter dated 1/6/2010. The letter identified the product being recalled and asked the consignee to immediately quarantine any product remaining at their facility. The recall should be conducted to the user level. Affected products at the consignee's facility and with their customers, should be returned using the instructions on the response form. The response forms are to completed and returned by fax or e-mail as indicated. Questions or the need for additional information concerning this recall should be directed to Sarah Larson at 903-677-9351 or [email protected].
Recall details
- Recall number
- Z-0764-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 6, 2009
- Posted by the FDA
- Feb 2, 2010
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 500 units
- Product code
- DRE
- FDA submissions
- K780126
- Distribution
- Nationwide Distribution -- State of CA.
Product description
Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA for VNUS, 5799 Fontanus Way, San Jose CA 95138 USA; General: 408-360-7200. For catheter exchange or placement of closed end catheters utilizing the Desilets-Hoffman technique.
Code information (models, lots, serial numbers)
Lot 99715418, Exp 2014-05.
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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