RunWay 6F Cardiovascular Guide Catheter.
This recall has been terminated (originally issued January 28, 2005).
- Company
- Boston Scientific Scimed
- Recall Initiated
- October 29, 2004
- Posted
- January 28, 2005
- Terminated
- November 10, 2006
- Recall Number
- Z-0454-05
- Quantity
- 76,984
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
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
Distribution
Throughout United States and into 15 other countries.
Lot / Code Info
all models and lot numbers of the Boston Scientific RunWay 6F Guide Catheter.
Root Cause
Other
Action Taken
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.