FDA Medical Device Recalls (openFDA)
Spectranetics Corporation: Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.
- Recall number
- Z-1264-2009
- Recalling firm
- Spectranetics Corporation
- Product
- Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.
- Status
- Terminated
- Initiated
- 2009-03-16
- Posted
- 2009-06-01
- Terminated
- 2011-11-28
- Reason
- Catheter outer jacket may split during use.
- 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
- 17 units
- Distribution
- Nationwide distribution: AL, KY, LA, MI, NC, NY, and PA.
- Lot, serial or model codes
- Lot number CJJ09B18A
- 510(k) numbers
- not on file
- PMA numbers
- ["P960042"]
- Product code
- OEX
- Firm FEI
- 3007284006
- Firm city
- Colorado Springs
- Firm state
- CO
- 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