Nimbus NIM-100-10BBRecalls & reported problems
Stratus Medical LLC · Electrosurgical RF Multitined Expandable Electrode · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850040767001), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2025Use of Device Problem; Use of Device Problem
ON NOVEMBER 20TH, 2025, STRATUS MEDICAL RECEIVED A COMPLAINT FROM A CLINICAL SPECIALIST ABOUT A SKIN BURN/WOUND THAT OCCURRED ON A GENICULAR RFA CASE ON (B)(6) 2025. THE FOLLOWING DESCRIPTION WAS PROVIDED: THE PHYSICIAN PERFORMED A LEFT GENICULAR RFA ON A 77-YEAR-OLD GENTLEMAN USING AN AVANOS COOLIEF GENERATOR. UPON COMPLETION OF THE PROCEDURE, THE PATIENT WAS DISCHARGED AND WENT HOME. FOUR DAYS LATER, THE PATIENT CALLED PHYSICIAN TO LET THEM KNOW THAT A BLISTER FORMED IN THE AREA OF ONE OF THE LESION SITES AFTER THE PATIENT GOT HOME, AND 4 DAYS LATER, IT RUPTURED, CAUSING AN OPEN WOUND. THE PATIENT CONSULTED WITH WOUND CARE. THE STRATUS MEDICAL CLINICAL SPECIALIST WAS MADE AWARE OF THE SKIN BURN/ WOUND ON NOVEMBER 20TH, 2025 AND THE PHYSICIAN PROVIDED PICTURES OF THE WOUND AND THE X-RAYS FROM THE PROCEDURE. THE PHYSICIAN SAID AT THE TIME OF THE PROCEDURE, THEY DID NOT NOTICE ANY REDNESS IN THE AREA OF THE BURN SITE, NOR DID THEY SEE ANY SKIN BURN WHEN THE NIMBUS WAS WITHDRAWN. UPON REVIEWING THE X-RAYS, THE PHYSICIAN MENTIONED THAT THEY REALIZED THE NEEDLE WAS HIGH ON THE TIBIA WHEN LOOKING BACK AT CASE AND SAID THE TISSUE WAS THINNER THERE.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 23856268 ↗
Other Probe, Radiofrequency Lesion devices
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- NA TCN-10-3MBoston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION2 recalls9 reports
- NA CSK-TC10Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall1 death58 reports
- NA CLASSICSt. Jude Medical, Inc. · PROBE, RADIOFREQUENCY LESION1 recall40 reports
- Intracept RLV 0055Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall30 reports
- Intracept RLV 0045Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall1 death23 reports
- Intracept RLV0065Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall14 reports
- NA CSK-TC5Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall3 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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