Distal Access Catheters — Class II medical device recall Z-0116-2016
Terminated recall by Concentric Medical Inc, reported 2015-10-21, distributed in KY. One Distal Access Catheter intended for distribution in Korea, was found at a US location.
| Recall number | Z-0116-2016 |
|---|---|
| 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 | 2015-08-19 |
| Classified | 2015-10-09 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2015-10-09 |
| Distributed | KY |
| Quantity | 1 |
| Lot numbers | 37603 |
| Model numbers | 90960 |
| Expiration dates | 2016-09-20 |
Product
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated 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 vasculatuure systems.
Reason for recall
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
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-0116-2016. 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.