Z-0454-05

RunWay 6F Cardiovascular Guide Catheter

Name: Z-0454-05 RunWay 6F Cardiovascular Guide Catheter
Creator: Boston Scientific Scimed
Published: 2004-10-29
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-10-29 / Terminated

FDA source

Boston Scientific Scimed began a recall of RunWay 6F Cardiovascular Guide Catheter on 2004-10-29. The reason FDA records is "The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0454-05
Status: Terminated
Initiated: 2004-10-29
Posted: 2005-01-28
Terminated: 2006-11-10
Recalling firm: Boston Scientific Corporation
Product: RunWay 6F Cardiovascular Guide Catheter.
Product code: DQY Catheter, Percutaneous
Reason for recall: The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent Delivery System balloon
FDA root cause: Other
Action: On 10/29/04 the Boston Scientific Sales force was notified via voice mail of the recall. Sales personnel were told to contact their accounts/customers by the end of the business day on 11/02/04. Accounts/customers were to receive written notice of the recall via Fed Ex on Monday 11/01/04. Sales Personnel are to ensure that accounts/customers got notice of the recall, understand instructions and are taking appropriate steps. Catheters are to be returned to Boston Scientific Corporation, Quincy, MA.
Quantity in commerce: 76,984
Distribution: Throughout United States and into 15 other countries.
Product codes and lots: all models and lot numbers of the Boston Scientific RunWay 6F Guide Catheter.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)