FDA Medical Device Recalls (openFDA)
Argon Medical Devices, Inc: MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
- Recall number
- Z-0051-2017
- Recalling firm
- Argon Medical Devices, Inc
- Product
- MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
- Status
- Terminated
- Initiated
- 2016-09-08
- Posted
- 2016-10-07
- Terminated
- 2017-06-07
- Reason
- The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath
- Root cause
- Nonconforming Material/Component
- Action
- An Urgent - Product Recall Notice was sent to consignees identifying the affected device and the reason for the recall. Customers were asked to return all affected devices. The firm will send replacement devices upon receipt of the returned affected product and once assembly of a cleared lot that does not contain recalled devices has been completed. If there are questions regarding the letter or recall action, customers can contact Beckie.Ellis@argonmedical.com.
- Quantity
- 200 units
- Distribution
- Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.
- Lot, serial or model codes
- 11149662, 11151447, 11151617, and 11149822.
- 510(k) numbers
- ["K071574"]
- PMA numbers
- not on file
- Product code
- DYB
- 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