NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter R-410-152Recalls & reported problems
North East Scientific Inc · Class 2
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
- Aug 29, 2025Class IIOpen, Classified
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Z-0018-2026 · Root cause: Process control · Recall details · FDA record ↗
Other Reprocessed Atherectomy Catheter devices
- NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter R-417-152North East Scientific Inc · Reprocessed Atherectomy Catheter1 recall0 reports
- NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter R-420-006North East Scientific Inc · Reprocessed Atherectomy Catheter1 recall0 reports
- NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter R-410-154North East Scientific Inc · Reprocessed Atherectomy Catheter1 recall0 reports
- NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter R-417-156North East Scientific Inc · Reprocessed Atherectomy Catheter1 recall0 reports
- NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter R-414-159North East Scientific Inc · Reprocessed Atherectomy Catheter1 recall0 reports
- NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter R-414-151North East Scientific Inc · Reprocessed Atherectomy Catheter1 recall0 reports
- NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter R-420-159North East Scientific Inc · Reprocessed Atherectomy Catheter1 recall0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page