SLS II Laser Sheath 500-012Recalls & reported problems
Spectranetics Corporation · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132020309), received between Jun 18, 2018 and Jun 18, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Crack1
Patient problems
- Radiation Exposure, Unintended1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2018Break; Crack; Break; Crack
Patient problems: Radiation Exposure, Unintended
MAUDE report 7611011 ↗
Other Device, Removal, Pacemaker Electrode, Percutaneous devices
- GlideLight Laser Sheath 500-303Spectranetics Corporation · Device, Removal, Pacemaker Electrode, Percutaneous63 deaths221 reports
- GlideLight Laser Sheath 500-302Spectranetics Corporation · Device, Removal, Pacemaker Electrode, Percutaneous39 deaths180 reports
- GlideLight Laser Sheath 500-301Spectranetics Corporation · Device, Removal, Pacemaker Electrode, Percutaneous3 deaths27 reports
- SLS II Laser Sheath 500-001Spectranetics Corporation · Device, Removal, Pacemaker Electrode, Percutaneous2 reports
- SLS II Laser Sheath 500-013Spectranetics Corporation · Device, Removal, Pacemaker Electrode, Percutaneous1 death2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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