Z-0948-2008

Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca...

Name: Z-0948-2008 Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca...
Creator: Kyphon Inc
Published: 2006-04-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-04-25 / Terminated / root cause: labeling and UDI

FDA source

Kyphon Inc began a recall of Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089 on 2006-04-25. The reason FDA records is "Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0948-2008
Status: Terminated
Initiated: 2006-04-25
Posted: 2008-02-05
Terminated: 2008-06-10
Recalling firm: Medtronic, Inc.
Product: Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089
Product code: BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Reason for recall: Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A customer advisory letter was sent on 4/25/06 to consignees. In some cases some were issued in person. Follow up with field representatives was also conducted. Both contacts involved providing IMPORTANT CHANGES IN INSTRUCTIONS FOR USE that are to be attached to the on site users documents. The recalling firm is updating future distribution with the new instructions for use.
Quantity in commerce: By Lot Number : J 6013102 = 147, Lot: J6033012 = 23
Distribution: Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA.
Product codes and lots: Lot Numbers: J6033012 and J6013102

Product code BSP

K043500Class IIFunctional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer NeedleInnospine, Inc. / cleared 2005-04-15

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)