Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus Endovascular Corporation. San Jose, CA

FDA Recall Z-1542-06 · Posted 2006-09-29

Recalling FirmMicrus Endovascular Corporation
Recall StatusTerminated
Product CodeDQX
Date Initiated2006-09-08
Date Terminated2007-06-29
Product Quantity413 units

Reason for Recall

During use, the introducer may cause the guide wire''s coating to strip off and may result in loose material which could break free and enter the blood stream.

Firm Action

On 9/8/06 the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

Root Cause

Other

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053265MICRUS GUIDE WIRE, WATUSI 0.014Micrus Endovascular Corporation · 2006-04-28

Official Source

View FDA Recall →

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

↑