Boston Scientific Scimed RunWay 6F Cardiovascular Guide Catheter. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RunWay 6F Cardiovascular Guide Catheter.
Brand
Boston Scientific Scimed
Lot Codes / Batch Numbers
all models and lot numbers of the Boston Scientific RunWay 6F Guide Catheter.
Products Sold
all models and lot numbers of the Boston Scientific RunWay 6F Guide Catheter.
Boston Scientific Scimed is recalling RunWay 6F Cardiovascular Guide Catheter. due to The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026