Turbo-Elite Laser Atherectomy Catheter 425-135-01Recalls & reported problems
Spectranetics Corporation · Class 2
All models of Turbo-Elite Laser Atherectomy Catheter (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Nov 25, 2024Class IIOpen, Classified
Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
Z-0680-2025 · Root cause: Device Design · Recall details · FDA record ↗
Other Catheter, Peripheral, Atherectomy devices
- HawkOne™ H1-MCovidien LP · Catheter, peripheral, atherectomy1 recall367 reports
- JETSTREAM™ XC 112266-001Boston Scientific Corporation · Catheter, peripheral, atherectomy288 reports
- JETSTREAM™ XC 112264-001Boston Scientific Corporation · Catheter, peripheral, atherectomy262 reports
- SET Rotarex®S 6F 135cm (Straub Medical®) Version 1.0Straub Medical AG · Catheter, Peripheral, Atherectomy2 deaths206 reports
- SET Rotarex™S 6 F x 135 cm 80237Straub Medical AG · Catheter, Peripheral, Atherectomy1 recall79 reports
- HawkOne™ H1-SCovidien LP · Catheter, peripheral, atherectomy1 recall70 reports
- Turbo-Elite Laser Atherectomy Catheter 420-006Spectranetics Corporation · Catheter, Peripheral, Atherectomy2 recalls19 reports
- Turbo-Elite Laser Atherectomy Catheter 417-152Spectranetics Corporation · Catheter, Peripheral, Atherectomy2 recalls16 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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