StraightShotRecalls & reported problems across all models
Medtronic Xomed, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 546
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 6 models of StraightShot by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 546 adverse event reports in the FDA's MAUDE database, received between Feb 6, 2017 and Sep 28, 2026 — classified as 2 injuries, 544 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (367 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 StraightShot problems
Device problems
- Overheating of Device367
- Vibration117
- Noise, Audible57
- Mechanical Jam55
- Device Remains Activated36
- Self-Activation or Keying23
- Mechanical Problem17
- Use of Device Problem17
Patient problems
- No Clinical Signs, Symptoms or Conditions472
- No Consequences Or Impact To Patient45
- No Patient Involvement20
- No Known Impact Or Consequence To Patient7
- Insufficient Information5
- Eye Injury1
- Hemorrhage/Blood Loss/Bleeding1
- Laceration(s)1
StraightShot models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- STRAIGHTSHOT® 1899200DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE373 reports
- STRAIGHTSHOT® 1899200DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE111 reports
- STRAIGHTSHOT® 1899200RFDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE32 reports
- StraightShot 1882040BUR, EAR, NOSE AND THROAT20 reports
- StraightShot 1882940BUR, EAR, NOSE AND THROAT5 reports
- StraightShot 1882040HRBUR, EAR, NOSE AND THROAT5 reports
Recent StraightShot adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Overheating of Device
It was reported that during intra op the device was getting so hot and did not feel comfortable using it. The procedure was delayed by 7 minutes in swapping handpieces. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910722 ↗MalfunctionSep 21, 2026Overheating of Device; Power Problem
It was reported that intra-op, the M5 handpiece handle sometimes gets stuck and heats up after using for a minute. The speed of the handpiece was 3000 RPM with irrigation 5cc/min. The procedure was completed with a backup handpiece. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836443 ↗MalfunctionSep 17, 2026Excessive Heating
It was reported that the device was sent for preventive maintenance. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801190 ↗MalfunctionSep 17, 2026Electrical /Electronic Property Problem; Overheating of Device
It was reported that intraoperative, handpiece was running hot and cable was tangled/lumpy. Procedure was completed with backup handpiece and there was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797770 ↗MalfunctionSep 16, 2026Vibration
It was reported that during Endoscopic septoplasty procedure the blade was rattling. The procedure was completed with replaced device. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785796 ↗MalfunctionSep 8, 2026Overheating of Device; Noise, Audible
It was reported that post-op, the M5 Handpiece was getting hot and making a buzzing noise, there was no delay in the case. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50661804 ↗MalfunctionAug 7, 2026Overheating of Device; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50170551 ↗MalfunctionJul 29, 2026Break; Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50069168 ↗MalfunctionJul 28, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058442 ↗MalfunctionJul 28, 2026Vibration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50049002 ↗MalfunctionJul 22, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25900754 ↗MalfunctionJul 14, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25809749 ↗MalfunctionJul 3, 2026Overheating of Device; Use of Device Problem
IT WAS REPORTED THAT PRE-OP, THE M5 HANDPIECE WAS GETTING HOT AND WAS NOT WORKING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25702521 ↗MalfunctionJul 1, 2026Overheating of Device; Physical Resistance/Sticking
IT WAS REPORTED THAT PRIOR TO USE, THE M5 HANDPIECE WAS OVERHEATING AND FINGER SWITCH STUCK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25679052 ↗MalfunctionJun 22, 2026Overheating of Device
IT WAS REPORTED THAT DURING USE, THE HANDPIECE WAS GETTING HOT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25573284 ↗
Other Medtronic Xomed, Inc. products
All Medtronic Xomed, Inc. devices →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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