Z-1091-04

ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by...

Name: Z-1091-04 ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by...
Creator: Fox Hollow Technologies
Published: 2004-06-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-06-17 / Terminated / root cause: sterility

FDA source

Fox Hollow Technologies began a recall of ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technologies, Redwood City, CA 94063 on 2004-06-17. The reason FDA records is "Devices for which sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1091-04
Status: Terminated
Initiated: 2004-06-17
Posted: 2004-07-20
Terminated: 2004-10-25
Recalling firm: Medtronic, Inc.
Product: ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technologies, Redwood City, CA 94063
Product code: ---
Reason for recall: Devices for which sterility may be compromised.
Root cause tag: sterility
FDA 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 in commerce: 127 units
Distribution: The product received nationwide distribution to 59 medical facilities/doctor's offices and 4 units distributed to firm's field agents.
Product codes and lots: Lot codes: 04052414 and 04052608

Product code ---

K024243Class IIReform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406Fox Hollow Technologies / cleared 2003-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)