FDA Device recall Z-1164-2014
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class II recall of Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664 by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1164-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-03 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | TX |
Product
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Reason
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.
Identifiers
| code_info | 2013040058 |
|---|
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-1164-2014%22
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