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U.S. Department of Health and Human Services

Class 2 Device Recall ReFORM/SilverHawk Peripheral Atherectomy Catheters

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 Class 2 Device Recall ReFORM/SilverHawk Peripheral Atherectomy Catheterssee related information
Date Initiated by FirmJune 17, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on October 25, 2004
Recall NumberZ-1091-04
Recall Event ID 29443
510(K)NumberK024243 
Product Classification unknown device name - Product Code ---
ProductReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technologies, Redwood City, CA 94063
Code Information Lot codes: 04052414 and 04052608
FEI Number 3004904811
Recalling Firm/
Manufacturer		 Fox Hollow Technologies
300 Saginaw Dr
Redwood City CA 94063-4743
For Additional Information ContactSuzon Lommel
650-421-8521
Manufacturer Reason
for Recall		Devices for which sterility may be compromised.
FDA Determined
Cause 2		Other
ActionOn 6/18/04, all consignees were notified via phone call, written letter and on-site visit by the firm's sales reps, informing them of the affected product and providing instructions on the recall.
Quantity in Commerce127 units
DistributionThe product received nationwide distribution to 59 medical facilities/doctor's offices and 4 units distributed to firm's field agents.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = ---
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