ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technologies, Redwood City, CA 94063 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technologies, Redwood City, CA 94063
Lot Codes / Batch Numbers
Lot codes: 04052414 and 04052608
Products Sold
Lot codes: 04052414 and 04052608
A medical device manufacturer is recalling ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured due to Devices for which sterility may be compromised.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices for which sterility may be compromised.
Recommended Action
Per FDA guidance
On 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026