FDA Medical Device Recalls (openFDA)
Fox Hollow Technologies: ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technologies, Redwood City, CA 94063
- Recall number
- Z-1091-04
- Recalling firm
- Fox Hollow Technologies
- Product
- ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technologies, Redwood City, CA 94063
- Status
- Terminated
- Initiated
- 2004-06-17
- Posted
- 2004-07-20
- Terminated
- 2004-10-25
- Reason
- Devices for which sterility may be compromised.
- Root cause
- Other
- Action
- 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.
- Quantity
- 127 units
- Distribution
- The product received nationwide distribution to 59 medical facilities/doctor's offices and 4 units distributed to firm's field agents.
- Lot, serial or model codes
- Lot codes: 04052414 and 04052608
- 510(k) numbers
- ["K024243"]
- PMA numbers
- not on file
- Product code
- ---
- Firm FEI
- 3004904811
- Firm city
- Redwood City
- 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