FDA Medical Device Recalls (openFDA)
Argon Medical Devices, Inc: 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.
- Recall number
- Z-1029-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-02-17
- Posted
- 2016-03-01
- Terminated
- 2017-03-08
- Reason
- 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
- Process control
- Action
- On February 17, a letter was sent to Medtronic notifying them of a voluntary recall.
- Quantity
- 2000 units
- Distribution
- Distributed in IL.
- Lot, serial or model codes
- Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)
- 510(k) numbers
- ["K780126"]
- PMA numbers
- not on file
- Product code
- DRE
- Firm FEI
- 1625425
- Firm city
- Athens
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28