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Terminated

RunWay 6F Cardiovascular Guide Catheter.

FDA Recall Z-0454-05 · Posted 2005-01-28

Recalling FirmBoston Scientific Scimed
Recall StatusTerminated
Product CodeDQY
Date Initiated2004-10-29
Date Terminated2006-11-10
Product Quantity76,984

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

Firm 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.

Root Cause

Other

Distribution Pattern

Throughout United States and into 15 other countries.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033441BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETERBoston Scientific Corp · 2003-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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