CoblationRecalls & reported problems across all models
Smith & Nephew, Inc. · 62 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,126
- Deaths reported
- 2
- Injuries reported
- 554
- Recalls
- 0
We found 62 models of Coblation by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 2,126 adverse event reports in the FDA's MAUDE database, received between May 5, 2017 and Sep 23, 2026 — classified as 2 deaths, 554 injuries, 1,570 malfunctions.
The most frequently reported specific device problem is “Break” (380 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 Coblation problems
Device problems
- Break380
- Material Separation278
- Detachment of Device or Device Component178
- Adverse Event Without Identified Device or Use Problem158
- Overheating of Device156
- Protective Measures Problem119
- Failure to Deliver Energy88
- Self-Activation or Keying76
Patient problems
- No Clinical Signs, Symptoms or Conditions1,175
- No Known Impact Or Consequence To Patient449
- Foreign Body In Patient102
- Burn(s)69
- No Information68
- Hemorrhage/Blood Loss/Bleeding63
- No Consequences Or Impact To Patient41
- No Patient Involvement34
Coblation models
62 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Coblation ASHA4250-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES219 reports
- COBLATION 72290038Electrosurgical, cutting & coagulation & accessories190 reports
- Coblation ASC4250-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES169 reports
- Coblation ASC4830-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES168 reports
- Coblation EIC5874-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES153 reports
- Coblation EIC5872-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES127 reports
- Coblation ASHA4830-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES121 reports
- Coblation EIC8872-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES87 reports
- COBLATION EICA5872-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES82 reports
- COBLATION 72290037ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES65 reports
- Coblation ASC4630-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES64 reports
- Coblation EIC8875-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES46 reports
- Coblation EIC8898-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 death40 reports
- Coblation EC8000-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES39 reports
- Coblation ASHA4730-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES37 reports
- Coblation ASC4730-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES31 reports
- Coblation ASC4251-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES30 reports
- Coblation ASH4250-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES30 reports
- Coblation EIC7070-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 death28 reports
- Coblation AC4050-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES28 reports
- Coblation EICA8898-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES28 reports
- Coblation ASH4830-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES27 reports
- COBLATION EC8001-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES22 reports
- Coblation ASCA5001-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES19 reports
- Coblation ACH4041-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES19 reports
- COBLATION EICA8872-01Electrosurgical, cutting & coagulation & accessories18 reports
- Coblation AC4340-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES16 reports
- Coblation EICA7070-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES16 reports
- Coblation EIC4845-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES15 reports
- Coblation EICA8875-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES15 reports
- Coblation AC4330-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES15 reports
- Coblation ASC1336-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES15 reports
- Coblation EIC8870-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES14 reports
- Coblation EICA5874-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES13 reports
- Coblation AC2823-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES11 reports
- COBLATION 72290105SELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES11 reports
- Coblation AC5531-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES10 reports
- Coblation EIC7071-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES9 reports
- Coblation AC1340-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES9 reports
- Coblation AC1345-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES7 reports
- Coblation EICA6895-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES7 reports
- Coblation EICA4845-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- Coblation AC2430-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- Coblation EIC4835-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- Coblation AC2340-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- Coblation EICA4835-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- Coblation EICA7071-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- Coblation EIC6895-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Coblation AC1830-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Coblation SDC01-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Coblation ASHA3730-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Coblation AC4045-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- COBLATION EICA8872-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Coblation A1325-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Coblation ASC2530-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Coblation ASC5500-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Coblation E2020-01INSTRUMENT, BENDING OR CONTOURING1 report
- Coblation K7920-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Coblation AC1336-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Coblation AC3525-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Coblation ASC3730-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Coblation EIC4857-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent Coblation adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Crack; Detachment of Device or Device Component
It was reported that, during surgery, the tip of two (2) SUPER TURBOVAC 90 ICW was cracked and fell off. however, the broken pieces were removed with tweezers. The procedure was resumed, with a non-significant delay, using an equivalent S+N back-up. No further complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863657 ↗MalfunctionSep 22, 2026Material Separation
It was reported that, during a hip arthroscopy surgery, three metal tips of one (1) MULTIVAC 50 XL ICW became stuck at the operative site; however, they were removed using the shaver's suction. The procedure was resumed, without any delay, using an equivalent S+N back-up. No further complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854092 ↗InjurySep 18, 2026Overheating of Device
It was reported that, during a shoulder arthroscopy surgery, one (1) SUPER TURBOVAC 90 ICW caused a second-degree skin burn at site where the black cable of the device has contact. A whitish appearance was observed at the edge of the incision. The procedure was resumed without any delay using the same S+N product. No further complications were reported.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 50813254 ↗MalfunctionSep 3, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576960 ↗MalfunctionSep 3, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576892 ↗MalfunctionSep 1, 2026Fracture
It was reported that during Adenoidectomy, the electrodes tip of one (1) PROCISE EZ VIEW COBLATOR II was broken. The procedure was resumed, without any delay, using an equivalent S+N back-up. No further complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545500 ↗MalfunctionAug 31, 2026Detachment of Device or Device Component
It was reported that, during rotator cuff suture surgery, part of the electrode of one (1) SUPER TURBOVAC 90 ICW fell off. The procedure was performed, using an equivalent S+N back-up; however, it is unknown if there was any surgical delay. No further complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524783 ↗MalfunctionAug 30, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50513098 ↗MalfunctionAug 27, 2026Material Separation
It was reported that, for an Adenotonsillectomy, it was noticed that the electrode of one (1) PROCISE EZ VIEW COBLATOR II snapped off. The procedure was performed, with non-significant delay, using an equivalent S+N back up product. No further complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50488193 ↗MalfunctionAug 16, 2026Material Separation
It was reported that, during a rhinology, electrodes of one (1) PROCISE EZ COBLATOR II came off from the device. The detached metal electrode was identified on a swab after the wand was wiped, and it was confirmed that no electrode material remained in the patient's mouth. The procedure was resumed after a non-significant delay using an equivalent S+N back up. No further complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266596 ↗MalfunctionAug 13, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245178 ↗MalfunctionAug 7, 2026Break
It was reported that, during a surgery, the electrode tip wire of one (1) PROCISE MAX COBLATOR II broke. The procedure was resumed using an equivalent S+N back-up and it is unknown whether this caused any delay. No further complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50184516 ↗MalfunctionJun 28, 2026Degraded
IT WAS REPORTED THAT, DURING A SYNOVECTOMY PROCEDURE, A SUPER MULTIVAC 50 TIP DISINTEGRATED AND THE WAND STOPPED WORKING. THE QUANTUM BOX DID NOT ALERT, AND THE SETTINGS WERE SET TO 9 AND 2. A C-ARM WAS TAKEN OUT TO MAKE SURE THERE WAS NOT ANY METAL LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A 30 MINUTE DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. THE PATIENT EXPERIENCED POST OPERATIVE SEVERE PAIN. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Pain
MAUDE report 25648523 ↗MalfunctionJun 27, 2026Break
IT WAS REPORTED THAT, DURING A SURGERY, THE ELECTRODE TIP OF ONE (1) SUPER TURBOVAC FELL OFF. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25647152 ↗MalfunctionJun 21, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A WRIST TFCC SURGERY, THE HEAD OF THE MICROBLATOR WAND FELL OFF. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25572667 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- TWINFIX48 models · 1,450 reports
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.
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