Z-1164-2014Class II

Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664

Name: Z-1164-2014 Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664
Creator: Boston Scientific Corporation
Published: 2014-03-03
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2014-03-03 / Terminated / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664 on 2014-03-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1164-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-03
Posted: 2014-03-10
Terminated: 2014-06-09
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: packaging
FDA 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 in commerce: 7
Distribution: TX and Russia
Product codes and lots: 2013040058

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1164-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1164-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-10

Product code DQY

K033441Class IIBoston Scientific 6F Runway Guide CatheterBoston Scientific Corp / cleared 2003-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)