RunWay 6F Cardiovascular Guide Catheter

Date posted by the FDA

Jan. 28, 2005

Status

Terminated

Filed by

Boston Scientific Scimed

Product

RunWay 6F Cardiovascular Guide Catheter.

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

Distribution pattern

Throughout United States and into 15 other countries.

Quantity

76,984

Codes and lots

all models and lot numbers of the Boston Scientific RunWay 6F Guide Catheter.

Recall started

Oct. 29, 2004

Device type

Catheter, Percutaneous

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-0454-05

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0454-05. The agency record governs; check it and the company before acting.