PlasmaBlade XRecalls & reported problems across all models
Medtronic Navigation, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 85
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 7 models of PlasmaBlade X by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2020 and Sep 10, 2026 — classified as 4 injuries, 81 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (22 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PlasmaBlade X problems
Device problems
- Peeled/Delaminated22
- Fire18
- Failure to Shut Off16
- Detachment of Device or Device Component9
- Melted9
- Activation Problem6
- Energy Output Problem4
- No Device Output4
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- No Consequences Or Impact To Patient8
- Burn(s)6
- Electric Shock2
- Cardiac Arrest1
- Foreign Body In Patient1
PlasmaBlade X models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PlasmaBlade™ X PS210-030SElectrosurgical, cutting & coagulation & accessories39 reports
- PlasmaBlade™ X PS210-030S-LIGHTElectrosurgical, cutting & coagulation & accessories19 reports
- PlasmaBlade™ X PS210-030S-LIGHTElectrosurgical, cutting & coagulation & accessories10 reports
- PlasmaBlade™ X PS210-030SElectrosurgical, cutting & coagulation & accessories6 reports
- PlasmaBlade™ X PS210-030S-LIGHTElectrosurgical, cutting & coagulation & accessories6 reports
- PlasmaBlade™ X PS200-040Electrosurgical, cutting & coagulation & accessories4 reports
- PlasmaBlade™ X PS200-040Electrosurgical, cutting & coagulation & accessories1 report
Recent PlasmaBlade X adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Fire
THE PLASMA BLADE CAUGHT FIRE. THE EQUIPMENT WAS NOT TOUCHING THE PATIENT WHEN THIS HAPPENED. NO HARM TO PATIENT IN ANYWAY. FLUIDS WERE ON THE FIELD AND THE FIRE WAS IMMEDIATELY PUT OUT. LOT#211006 EXP:10-31-2028 REFERENCE# PS210-030S.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713860 ↗MalfunctionAug 25, 2026Smoking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50433037 ↗InjuryAug 14, 2026Fire
Information was received from a healthcare provider regarding a handpiece. It was reported that during pacemaker replacement surgery the surgical site was re-prepped with an alcohol-based chlorhexidine solution following patient movement and difficulty securing IV access, which required multiple interventions. A significant amount of the antiseptic solution migrated beneath the surgical drape and saturated the underlying draping material. The handpiece was then activated before the alcohol vapors had fully dissipated, resulting in ignition and a fire beneath the drape. The fire was extinguished within approximately one minute; however, the patient sustained second- and third-degree burns. No product defect was identified.
Patient problems: Burn(s)
MAUDE report 50251414 ↗MalfunctionJun 8, 2026Peeled/Delaminated
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THE PROTECTIVE POLYETHYLENE COATING AROUND LEAD OF THE HANDPIECE WAS DAMAGED DURING A GENERATOR CHANGEOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25425064 ↗MalfunctionMay 27, 2026Detachment of Device or Device Component
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT DURING INTRA-OPERATIVE USE, THE PIECE OF PROTECTIVE SHEATH DETACHED FROM HANDPIECE. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25296494 ↗MalfunctionMay 25, 2026Failure to Shut Off
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT ONCE THE COAG BUTTON OF THE HANDPIECE WAS DEPRESSED, THE ENERGY CONTINUED TO RUN AS THE BUTTON WAS STUCK IN THE ON POSITION. A PATIENT WAS INVOLVED BUT THERE WAS NO IMPACT ON THE PATIENT OUTCOME. THERE WAS NO DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25268234 ↗MalfunctionMay 19, 2026Electromagnetic Interference
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT WHEN CUT OR COAG ON THE HANDLE OF THE HANDPIECE WAS PRESSED, OTHER DEVICE MAGNETIC BREAKS WOULD LOCK OR UNLOCK. A PATIENT WAS INVOLVED BUT THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. THERE WAS NO DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25214595 ↗MalfunctionApr 6, 2026Fire
2026-MAR-11 00875614 SAP ECC SERVICE AND REPAIR 000304554782 (HCP): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT, DURING SURGERY, A HANDPIECE PRODUCED SPARKS, AND SPARKS WERE ALSO OBSERVED COMING OUT OF THE GENERATOR. THE ISSUE OCCURRED INTRA-OPERATIVELY, PATIENT WAS INVOLVED BUT NO REPORTED IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24796244 ↗MalfunctionDec 26, 2025Fire; Fire
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A HANDPIECE. IT WAS REPORTED THAT DURING A PROCEDURE THE SPARKS WERE OBSERVED COMING FROM THE TIP OF THE HANDPIECE DURING OPERATION. UPON SEEING THE SPARKS, THE SURGEON CHOSE NOT TO USE THE PRODUCT AND OPENED A NEW PIECE INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894809 ↗MalfunctionAug 25, 2025Failure to Shut Off; Activation Problem; Failure to Shut Off; Activation Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A FESS, THE HANDPIECE WAS NOT TURNING OFF WHILE ON COAGULATION MODE, THE TRIGGER WAS RELEASED, BUT THE DEVICE CONTINUED TO ACTIVATE. AS A RESULT, USE OF THE HANDPIECE WAS ABANDONED AND ANOTHER HANDPIECE WAS BROUGHT IN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882236 ↗MalfunctionMay 7, 2025Activation Problem; Activation Problem
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A LUMPECTOMY PROCEDURE, THE HANDPIECE WAS UNRESPONSIVE, SWITCHING FROM COAG TO CUT. THE ISSUE OCCURRED INTRAOPERATIVELY, CASE CONTINUED BY OPENING UP ANOTHER HANDPIECE, AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED IMPACT ON PATIENT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21975134 ↗MalfunctionApr 30, 2025Activation Problem; Activation Problem
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A LUMPECTOMY PROCEDURE, THE HANDPIECE WAS UNRESPONSIVE, SWITCHING FROM COAG TO CUT. THE ISSUE OCCURRED INTRAOPERATIVELY, ANDCASE CONTINUED BY OPENING UP ANOTHER HANDPIECE, AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932599 ↗MalfunctionFeb 10, 2025Melted; Melted
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A HIP REVISION SURGERY, THE PLASTIC ON THE HANDPIECE WAS MELTED. THE HANDPIECE WAS USED AGAINST METAL, SUCH AS A HEMOSTAT, WHICH WAS LIKELY THE CAUSE OF THE MELTING. ONCE THE ISSUE OCCURRED, THE SURGICAL TEAM SWITCHED TO USING A OTHER HANDPIECE. THE INCIDENT HAPPENED TOWARDS THE END OF THE PROCEDURE, WHICH LASTED ALMOST FOUR HOURS. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR AND WAS NO REPORTED IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343260 ↗MalfunctionJan 8, 2025Fire; Fire
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT WHEN HANDPIECE WAS ACTIVATED THE FIRE WAS COMING OUT OF THE TIP. SITE USED HANDPIECE INTRA-OPERATIVELY FOR A BREAST CASE. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. ADDITIONAL INFORMATION WAS RECEIVED, SALES REPRESENTATIVE (REP) CONFIRMED THAT THE COMPLAINT WAS ONLY WITH ONE INSTRUMENT AND THE OTHER INSTRUMENT WAS BEING REQUESTED TO REPLACE DUE TO THE FIRE HAPPENED. HOWEVER, SITE PULLED ANOTHER DEVICE TO TEST THE GENERATOR. NO REPORTED IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21102790 ↗MalfunctionDec 9, 2024Electromagnetic Interference; Noise, Audible; Electromagnetic Interference; Noise, Audible
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A SURGERY INVOLVING THE REPLACEMENT OF A DEEP BRAIN STIMULATION DEVICE, A STRANGE SOUND, DESCRIBED AS SIMILAR TO THE NOISE OF A HONEYBEE, WAS EMITTED FROM THE HANDPIECE. THE PATIENT, WHO WAS UNDERGOING THE PROCEDURE UNDER LOCAL ANESTHESIA, REPORTED FEELING CURRENTS IN THE AREA AROUND THE EXISTING DEVICE. THE SETTINGS ON THE GENERATOR WERE CUT 5 AND COAG 6. THE ISSUE WAS OBSERVED INTR A-OPERATIVELY, AND THE SURGEON DECIDED TO STOP USING THE HANDPIECE FOR THE REMAINDER OF THE SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER USE OF THE DEVICE. THE SITE ALSO MENTIONED THAT THEY BELIEVE THE PUMP COVER FIT TOO LOOSELY AND WERE CONCERNED THAT SURFACE DISINFECTANT COULD FLOW INTO THE GENERATOR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A DELAY OF AROUND 10 MIN DUE TO THE SOUND CHECK OF THE GENERATOR AND HANDPIECE.
Patient problems: Electric Shock
MAUDE report 20878792 ↗
Other Medtronic Navigation, Inc. products
- O-ARM17 models · 9,235 reports · 5 recalls
- StealthStation S8 Platform14 models · 8,402 reports
- Stealthstation S711 models · 5,756 reports
- StealthStation S86 models · 2,235 reports
- Fusion ENT Image Guidance System5 models · 2,033 reports
- Visualase25 models · 625 reports · 3 recalls
- NavLock9 models · 134 reports · 1 recall
- AxiEM12 models · 62 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page