Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.
This recall has been terminated (originally issued June 1, 2009).
- Company
- Spectranetics Corporation
- Recall Initiated
- March 16, 2009
- Posted
- June 1, 2009
- Terminated
- November 28, 2011
- Recall Number
- Z-1264-2009
- Quantity
- 17 units
- Firm Location
- Colorado Springs, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Catheter outer jacket may split during use.
Distribution
Nationwide distribution: AL, KY, LA, MI, NC, NY, and PA.
Lot / Code Info
Lot number CJJ09B18A
Root Cause
Process control
Action Taken
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.
More recalls by Spectranetics Corporation
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) followi...
Feb 14, 2025
Turbo Elite Laser Atherectomy Catheter
Model Number / UDI-DI code / Product Description
414-151 / 98...
Dec 16, 2024
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159
Spectranetics Turbo-Elite L...
Dec 8, 2023