Z-1264-2009

Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer

Name: Z-1264-2009 Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer
Creator: Spectranetics Corporation
Published: 2009-03-16
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2009-03-16 / Terminated / root cause: manufacturing process

FDA source

Spectranetics Corporation began a recall of Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer on 2009-03-16. The reason FDA records is "Catheter outer jacket may split during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1264-2009
Status: Terminated
Initiated: 2009-03-16
Posted: 2009-06-01
Terminated: 2011-11-28
Recalling firm: Spectranetics Corp.
Product: Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.
Product code: OEX Cardiovascular Catheter Sheath Introducer Kit
Reason for recall: Catheter outer jacket may split during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Spectranetics notified the 8 recipients of the catheters by letter on 3/17/2009. They were told that a Spectranetics sales rep would contact them to coordinate the return of the suspect devices. Questions were referred to 719-447-2462 or 719-447-2539.
Quantity in commerce: 17 units
Distribution: Nationwide distribution: AL, KY, LA, MI, NC, NY, and PA.
Product codes and lots: Lot number CJJ09B18A

Product code OEX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)