OptaBlateRecalls & reported problems across all models
Stryker Corporation · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 8 models of OptaBlate by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2023 and Sep 1, 2026 — classified as 4 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Fracture” (16 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 OptaBlate problems
Device problems
- Fracture16
- No Apparent Adverse Event4
Patient problems
- Foreign Body In Patient11
- No Clinical Signs, Symptoms or Conditions6
- Paralysis2
- Insufficient Information1
- Paresis1
- Spinal Cord Injury1
OptaBlate models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OptaBlate 9900110200Probe, radiofrequency lesion6 reports
- OptaBlate 9900110100Probe, radiofrequency lesion4 reports
- OptaBlate 9700015200Electrosurgical, cutting & coagulation & accessories3 reports
- OptaBlate 9700020200Electrosurgical, cutting & coagulation & accessories2 reports
- OptaBlate 9700120000Electrosurgical, cutting & coagulation & accessories2 reports
- OptaBlate 9700115000Electrosurgical, cutting & coagulation & accessories2 reports
- OPTABLATE 9700000000Electrosurgical, cutting & coagulation & accessories1 report
- OptaBlate 9700811000spinal channeling instrument, vertebroplasty1 report
Recent OptaBlate adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Fracture
Patient problems: Foreign Body In Patient
MAUDE report 50541909 ↗MalfunctionAug 25, 2026Fracture
Patient problems: Foreign Body In Patient
MAUDE report 50430783 ↗MalfunctionMay 28, 2026Fracture
IT WAS REPORTED THE OMNICURVE PEAK SHEATH BROKE OFF IN THE PATIENT BUT WAS ABLE TO BE REMOVED. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25319642 ↗MalfunctionApr 14, 2026Fracture
IT WAS REPORTED THE OMNICURVE PEAK SHEATH WAS LEFT IN THE PATIENT. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 24877127 ↗MalfunctionApr 8, 2026Fracture
IT WAS REPORTED THAT THE TIP OF THE OPTABLATE PROBE BROKE AFTER ABLATING WHILE THE DOCTOR WAS REMOVING IT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821578 ↗MalfunctionApr 8, 2026Fracture
IT WAS REPORTED THAT THE PROBE EMITTER BROKE AND WAS LEFT IN THE PATIENT. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Foreign Body In Patient
MAUDE report 24816533 ↗MalfunctionMar 16, 2026
PROBE EMTTER BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604311 ↗MalfunctionMar 5, 2026Fracture
IT WAS REPORTED THAT THE OMNICURVE PEAK SHEATH BROKE OFF IN THE PATIENT AND WAS REMOVED BY THE SURGEON. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518875 ↗MalfunctionFeb 12, 2026Fracture
MalfunctionFeb 6, 2026Fracture
IT WAS REPORTED THE OMNICURVE PEAK SHEATH WAS LEFT IN THE PATIENT. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 24278196 ↗MalfunctionJan 14, 2026Fracture
IT WAS REPORTED THE OMNICURVE PEAK SHEATH WAS LEFT IN THE PATIENT. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 24070028 ↗MalfunctionJan 8, 2026Fracture
IT WAS REPORTED THE OMNICURVE PEAK SHEATH WAS LEFT IN THE PATIENT. THERE WAS NO MEDICAL INTERVENTION AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 24003897 ↗MalfunctionDec 22, 2025Fracture; Fracture
IT WAS REPORTED THE OMNICURVE PEAK SHEATH WAS LEFT IN THE PATIENT. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Foreign Body In Patient
MAUDE report 23871879 ↗MalfunctionOct 29, 2025Fracture; Fracture
MalfunctionOct 23, 2025Fracture; Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: Foreign Body In Patient
MAUDE report 23368870 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 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.
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