OptaBlate 9900110200Recalls & reported problems
Stryker Corporation · BVN Probe Dual Kit · Class 2
All models of OptaBlate (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327601169), received between Oct 29, 2025 and Aug 25, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture6
Patient problems
- Foreign Body In Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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 ↗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 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 ↗MalfunctionOct 29, 2025Fracture; Fracture
Other Probe, radiofrequency lesion devices
- NA TCN-15Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION2 recalls10 reports
- NA TCN-10-3MBoston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION2 recalls9 reports
- NA CSK-TC10Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall1 death58 reports
- NA CLASSICSt. Jude Medical, Inc. · PROBE, RADIOFREQUENCY LESION1 recall40 reports
- Intracept RLV 0055Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall30 reports
- Intracept RLV 0045Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall1 death23 reports
- Intracept RLV0065Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall14 reports
- NA CSK-TC5Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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