FDA Medical Device Recalls (openFDA)
Boston Scientific Scimed: RunWay 6F Cardiovascular Guide Catheter.
- Recall number
- Z-0454-05
- Recalling firm
- Boston Scientific Scimed
- Product
- RunWay 6F Cardiovascular Guide Catheter.
- Status
- Terminated
- Initiated
- 2004-10-29
- Posted
- 2005-01-28
- Terminated
- 2006-11-10
- Reason
- 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
- 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
- 76,984
- Distribution
- Throughout United States and into 15 other countries.
- Lot, serial or model codes
- all models and lot numbers of the Boston Scientific RunWay 6F Guide Catheter.
- 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