Boston Scientific — Class II medical device recall Z-1164-2014
Terminated recall by Boston Scientific Corporation, reported 2014-03-19, distributed in TX. The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised.
| Recall number | Z-1164-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2014-03-03 |
| Classified | 2014-03-10 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2014-06-09 |
| Distributed | TX |
| Countries outside the US | RU |
| Quantity | 7 |
| Reason classes | sterility |
| Model numbers | 38969-664 |
Product
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Reason for recall
The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
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-1164-2014. 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.