FDA Device recall Z-0525-2015
Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160 by Concentric Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0525-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-26 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Concentric Medical |
| Distribution | AL, AZ, CA, FL, IL, KY, MA, MI, MS, NC, NY, OK, PA, TN, TX, VA, WA |
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.
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.
Identifiers
| code_info | Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0525-2015%22
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