Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1542-06

Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus...

Micrus Endovascular Corporation / initiated 2006-09-08 / Terminated

Micrus Endovascular Corporation began a recall of Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus Endovascular Corporation. San Jose, CA on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1542-06
Status
Terminated
Initiated
Posted
Terminated
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
Product code
DQX Wire, Guide, Catheter
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.
FDA 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 in commerce
413 units
Distribution
Worldwide
Product codes and lots
All lots including F22741, F22742, F22743, F22744, F22745, F22746, F22747, F22749.