OptaBlate 9900110100Recalls & reported problems
Stryker Corporation · BVN Probe Single Kit · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327601121), received between Dec 22, 2025 and Sep 1, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture4
Patient problems
- Foreign Body In Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Fracture
Patient problems: Foreign Body In Patient
MAUDE report 50541909 ↗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 ↗
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
- Intracept RLV 0075Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.