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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-1542-06
Recalling firm
Micrus Endovascular Corporation
Product
Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus Endovascular Corporation. San Jose, CA
Status
Terminated
Initiated
2006-09-08
Posted
2006-09-29
Terminated
2007-06-29
Reason
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.
Root cause
Other
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.
Quantity
413 units
Distribution
Worldwide
Lot, serial or model codes
All lots including F22741, F22742, F22743, F22744, F22745, F22746, F22747, F22749.
510(k) numbers
["K053265"]
PMA numbers
not on file
Product code
DQX
Firm FEI
3003079393
Firm city
San Jose
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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