TruClearRecalls & reported problems across all models
Covidien LP · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one TruClear model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 294
- Deaths reported
- 0
- Injuries reported
- 62
- Recalls
- 1
We found 20 models of TruClear by Covidien LP in the FDA's device registry (GUDID). Together they are named in 294 adverse event reports in the FDA's MAUDE database, received between Sep 15, 2017 and Sep 28, 2026 — classified as 62 injuries, 232 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (65 reports).
1 FDA recall record name at least one of these models by its device 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. 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
TruClear recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 7, 2022Open, Classified
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
Z-1467-2022 · Root cause: Device Design · Recall details · FDA record ↗
Most reported TruClear problems
Device problems
- Adverse Event Without Identified Device or Use Problem67
- Material Protrusion/Extrusion65
- Break44
- Detachment of Device or Device Component43
- Material Fragmentation35
- Material Deformation27
- Mechanical Jam21
- Appropriate Device Problem Term/Code Not Available20
Patient problems
- No Clinical Signs, Symptoms or Conditions153
- Insufficient Information33
- No Patient Involvement32
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available22
- No Consequences Or Impact To Patient17
- Hemorrhage/Blood Loss/Bleeding9
- No Information9
- No Code Available8
TruClear models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TruClear 7209808HYSTEROSCOPE (AND ACCESSORIES)1 recall32 reports
- TruClear 72202536HYSTEROSCOPE (AND ACCESSORIES)48 reports
- TruClear 72204878HYSTEROSCOPE (AND ACCESSORIES)42 reports
- TruClear 72203012HYSTEROSCOPE (AND ACCESSORIES)34 reports
- TruClear 72204878SHYSTEROSCOPE (AND ACCESSORIES)31 reports
- TruClear 72204064HYSTEROSCOPE (AND ACCESSORIES)29 reports
- TruClear 7209807HYSTEROSCOPE (AND ACCESSORIES)27 reports
- TruClear 7209807SHYSTEROSCOPE (AND ACCESSORIES)10 reports
- TruClear 72204879HYSTEROSCOPE (AND ACCESSORIES)9 reports
- TruClear 7209208HYSTEROSCOPE (AND ACCESSORIES)7 reports
- TruClear 7209820HYSTEROSCOPE (AND ACCESSORIES)7 reports
- TruClear 7209509HYSTEROSCOPE (AND ACCESSORIES)4 reports
- TruClear 72204752HYSTEROSCOPE (AND ACCESSORIES)3 reports
- TruClear 7209808SHYSTEROSCOPE (AND ACCESSORIES)3 reports
- TruClear 72204753HYSTEROSCOPE (AND ACCESSORIES)2 reports
- TruClear 72204879SHYSTEROSCOPE (AND ACCESSORIES)2 reports
- TruClear 72205066HYSTEROSCOPE (AND ACCESSORIES)1 report
- TruClear 72204752HYSTEROSCOPE (AND ACCESSORIES)1 report
- TruClear 72204752SHYSTEROSCOPE (AND ACCESSORIES)1 report
- TruClear 7209383HYSTEROSCOPE (AND ACCESSORIES)1 report
Recent TruClear adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926382 ↗MalfunctionSep 24, 2026Material Deformation; Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892025 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
It was reported that a scope had a chipped tip prior to use. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728088 ↗MalfunctionSep 11, 2026Material Protrusion/Extrusion
It was reported that during demonstration, the device had a broken shaft where there was a sharp edge on the bevel. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50726857 ↗MalfunctionSep 8, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671108 ↗MalfunctionSep 8, 2026Detachment of Device or Device Component
It was reported that during the procedure, the inner-tube of the blade was broken. The fracture occurred inside the handpiece. No device fragments detached or entered the patient's body. They completed the procedure with an alternative method. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50668659 ↗MalfunctionAug 31, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515054 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222303 ↗MalfunctionAug 3, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122244 ↗MalfunctionJul 30, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084753 ↗MalfunctionJun 15, 2026Material Protrusion/Extrusion
IT WAS REPORTED THAT PRIOR TO USE, THE SCOPE WAS OBSERVED TO HAVE A SHARP DISTAL END. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25504775 ↗MalfunctionMay 13, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A HYSTEROSCOPY WITH DEVICE FOR FIBROID RESECTION, THE DEVICE SHAFT BROKE NEAR THE PLASTIC PIECE WHILE THE MINI DENSE BLADE WAS BEING USED, WITH THE SHAFT BREAKING OFF OF THE PLASTIC PART. ANOTHER SHAVER WAS USED TO COMPLETE THE PROCEDURE. NO DEVICE COMPONENT FELL INTO THE PATIENT CAVITY. X-RAY WAS NOT NEEDED TO FIND AND RETRIEVE THE BROKEN PIECE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25158338 ↗MalfunctionMay 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, PRIOR TO A HYSTEROSCOPY AND CURETTAGE PROCEDURE, UNIDENTIFIED FRAGMENTS WERE OBSERVED FALLING FROM THE SHAVER TIP. THE SHAVER WAS REPLACED WITH A NEW SHAVER TO CONTINUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150957 ↗MalfunctionMay 7, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO A HYSTEROSCOPY AND CURETTAGE PROCEDURE, UNIDENTIFIED FRAGMENTS WERE OBSERVED FALLING FROM THE SHAVER TIP. THEY IMMEDIATELY REPLACED THE DEVICE WITH ANOTHER BRAND-NEW SHAVER TO COMPLETE THE PROCEDURE. NOTHING FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO INVASION OF THE PATIENT AT THE TIME THE FRAGMENTS WERE OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25115894 ↗MalfunctionMay 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING HYSTEROSCOPY, A DEVICE COMPLETELY BROKE OFF. THE PHYSICIAN STATED THAT THE SHAVER WAS NOT USED AGGRESSIVELY OR ROUGHLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25081184 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
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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