FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
- Recall number
- Z-1164-2014
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
- Status
- Terminated
- Initiated
- 2014-03-03
- Posted
- 2014-03-10
- Terminated
- 2014-06-09
- 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.
- Root cause
- Packaging
- Action
- Consignees were sent a Boston Scientific "Urgent Medical Device Recall Removal " letter dated March 3, 2014. The letter described the problem and the product involved in the recall. The letter advised consignees to return the affected product and to complete and return the Account Reply Verification Tracking Form. The local Sales Representative can answer any questions that you may have regarding this Recall Removal.
- Quantity
- 7
- Distribution
- TX and Russia
- Lot, serial or model codes
- 2013040058
- 510(k) numbers
- ["K033441"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28