Device, Angioplasty, Laser, Coronary
FDA adverse event reports and recall history for device, angioplasty, laser, coronary (product code LPC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 295
- Deaths
- 33
- Injuries
- 180
- Malfunctions
- 78
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2022-11-11Open, ClassifiedDevice Design
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.
- 2016-11-28TerminatedPackaging
ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
- 2012-04-11TerminatedNonconforming Material/Component
12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.
- Open, ClassifiedDevice Design
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.
Monitor device, angioplasty, laser, coronary automatically
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