Z-1495-06

CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company...

Name: Z-1495-06 CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company...
Creator: Cordis Corporation
Published: 2006-07-21
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2006-07-21 / Terminated

FDA source

Cordis Corporation began a recall of CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami... on 2006-07-21. The reason FDA records is "Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1495-06
Status: Terminated
Initiated: 2006-07-21
Posted: 2006-09-09
Terminated: 2008-11-19
Recalling firm: Cordis US Corp.
Product: CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA, Catalog # 503658X
Product code: DXQ Blood Pressure Cuff
Reason for recall: Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.
FDA root cause: Other
Action: A recall of all lots manufactured by the OEM was initiated by letter dated July 21, 2006. All lots of the SV-5 guidewire and related design SV-8 guidewire were placed on Stop Shipment 6/30/06.
Quantity in commerce: 740
Distribution: World wide Distribution-USA and Japan, Canada, Panama, Peru, Puerto Rico, Uruguay, Mexico and The Netherlands
Product codes and lots: 70306851 70406742 70406769 70506720 70506777

Product code DXQ

K930091Class IICordis Reflex Steerable GuidewireCordis Corp. / cleared 1993-04-07

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)