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Terminated

Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Hook Tip Shape, CS-H, REF 7438

FDA Recall Z-0800-04 · Posted 2004-07-20

Recalling FirmGuidant Corp-Cpi Division
Recall StatusTerminated
Product CodeDQR
Date Initiated2004-03-11
Date Terminated2005-10-31
Product Quantity245 catheters

Reason for Recall

The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.

Firm Action

Starting on March 11, 2003, the firm''s representatives visited consignees, to whom the recalled catheters had been consigned, and retrieved the catheters.

Root Cause

Other

Distribution Pattern

Nationwide in the United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021455RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,Guidant Corp. · 2002-08-02K021284EASYTRAK GUIDING CATHETERGuidant Corp. · 2002-05-02

Official Source

View FDA Recall →

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

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