FDA Medical Device Recalls (openFDA)
Concentric Medical Inc: Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
- Recall number
- Z-0525-2015
- Recalling firm
- Concentric Medical Inc
- Product
- Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
- Status
- Terminated
- Initiated
- 2013-09-26
- Posted
- 2014-12-12
- Terminated
- 2014-12-08
- Reason
- Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.
- Root cause
- Labeling mix-ups
- Action
- The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated September 26, 2013 consignees/customers at all affected sites by registered mail. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately locate the subject devices and quarantine them; distribute notice to all affected departments in your facility; inform Concentric Medical (Stryker Neuovascular) if any of the subject devices have been distributed to other organizations; complete, sign and return the attached Customer Response Form via Fax to: 1-866-876-4355 or email a copy to: NeuroComplaints@stryker.com, complete form even if you do not have any subject devices to return, and keep a copy of the completed, signed Customer Response Form for your records. Should you have any queries concerning this matter, please do not hesitate to contact the QA Manager at 650-810-1716.
- Quantity
- 87 units
- Distribution
- US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.
- Lot, serial or model codes
- Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number 36050: 09-2014 Lot Number 36017: 09-2014 Lot Number 36029: 09-2014 Lot Number 35583: 02-2014
- 510(k) numbers
- ["K110483"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3003271051
- Firm city
- Mountain View
- Firm state
- CA
- 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