Distal Access Catheter: Model Numbers: 90121 — Class II medical device recall Z-0525-2015
Terminated recall by Concentric Medical Inc, reported 2014-12-17, distributed in AL, AZ, CA, FL, IL, KY, MA, MI…. Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions fo
| Recall number | Z-0525-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Concentric Medical Inc, Mountain View, CA, United States |
| Recall initiated | 2013-09-26 |
| Classified | 2014-12-08 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2014-12-08 |
| Distributed | AL, AZ, CA, FL, IL, KY, MA, MI, MS, NC, NY, OK, PA, TN, TX, VA, WA |
| Quantity | 87 units |
| Lot numbers | 35583, 35767, 35951, 35980, 36007, 36017, 36029, 36050 |
| Model numbers | 90121, 90130, 90131, 90160 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0525-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.