Every recall we track for Spectranetics Corporation — 9 in all — plus the complaints and injury reports the public filed about them.
Spectranetics recalls vascular tack endovascular systems used to treat arterial dissections post-angioplasty due to potential deployment instability causing device failure or complications.
Spectranetics recalls Turbo-Elite Laser Atherectomy Catheters due to mismatched product labels on exterior boxes and internal pouches. This labeling error may cause confusion in medical use.
Philips LAS-100 laser systems used in cardiovascular procedures may enter non-recoverable safe state causing treatment delays. Affected units have specific serial numbers. Contact Philips for details.
Philips LAS-100 Laser systems with serial numbers 100000-100104 may intermittently stop working due to hardware errors during power-up. Affected units require specific troubleshooting to resolve intermittent operation issues.
Spectranetics recalls Bridge Occlusion Balloon REF 590-001 due to potential blood clot formation if left in blood vessels too long. All users should minimize balloon time in vasculature to prevent embolization.
Spectranetics recalls AngioSculpt PTCA Scoring Balloon Catheter (2.5mm outer diameter) due to incorrect carton box used. Affected units may have packaging issues but no safety hazard is reported.
