Strykeprobe 0250070460Recalls & reported problems
Stryker Corporation · Outer Sheath Replacement · Class 2
All models of Strykeprobe (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Strykeprobe is an electrosurgical probe with a replaceable outer sheath. The 35 reports mostly describe insulation melting or arcing, sometimes with burning, breakage, or overheating; they mention 3 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07613327051971), received between Jun 4, 2018 and Jun 12, 2026 — classified as 3 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Melted” (14 reports).
1 other recall cover devices cleared under the same FDA submission (K963765); they may or may not involve this specific model.
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
- Melted14
- Arcing9
- Break4
- Overheating of Device3
- Temperature Problem3
- Adverse Event Without Identified Device or Use Problem2
- Excessive Heating2
- Material Fragmentation2
Patient problems
- No Known Impact Or Consequence To Patient24
- No Clinical Signs, Symptoms or Conditions9
- Burn(s)2
- No Consequences Or Impact To Patient2
- Foreign Body In Patient1
- Injury1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Overheating of Device; Temperature Problem
It was reported that the outer sheaths that look like it had some arcing and looked burnt during the case. They were looking at the L hooks, and it seems like the yellow insulation does not go all the way up to the hub. This happened during a case but no patient harm happened.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25487283 ↗MalfunctionNov 15, 2024Arcing; Temperature Problem; Arcing; Temperature Problem
IT WAS REPORTED THERE DAMAGED/COMPROMISED INSULATION AND ARCING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696054 ↗MalfunctionJul 3, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING HYSTEROSCOPY PROCEDURE THERE WAS DAMAGED/COMPROMISED INSULATION WHICH RESULTED IN PATIENT BURN. THE BURN OCCURRED IN THE UTERUS, WHICH WAS REMOVED AS PART OF THE HYSTEROSCOPY PROCEDURE, AND THEREFORE DID NOT RESULT IN PERMANENT IMPAIRMENT, IS NOT LIFE THREATENING, OR NECESSITATE UNPLANNED MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19667822 ↗InjuryMay 23, 2024Arcing; Material Too Soft/Flexible; Arcing; Material Too Soft/Flexible
IT WAS REPORTED THAT THE DEVICE ARCHED AND BURNED THE PATIENT REQUIRING A SUTURE REPAIR.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 19387688 ↗MalfunctionMay 13, 2024Melted; Melted
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT DUE TO DEVICE CATCHING ON FIRE. NO PATIENT HARM NO ADVERSE CONSEQUENCES NO MEDICAL INTERVENTION. THE PROBE DID NOT CATCH FIRE IN A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19299206 ↗MalfunctionApr 3, 2024Thermal Decomposition of Device; Temperature Problem; Thermal Decomposition of Device; Temperature Problem
IT WAS REPORTED THAT THE INSULATION WAS COMPROMISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19038220 ↗MalfunctionDec 13, 2023Fire; Fire
IT WAS REPORTED THAT THE DEVICE CAUGHT ON FIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18323173 ↗MalfunctionApr 28, 2022Arcing; Sparking
IT WAS REPORTED THAT THE DEVICE ARCED/SPARKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14240178 ↗MalfunctionDec 7, 2021Break
IT WAS REPORTED THAT THE SHEATH BROKE AND POTENTIALLY REMAINED INSIDE THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 12955049 ↗MalfunctionNov 12, 2019Arcing
IT WAS REPORTED THAT THERE WAS A POTENTIAL FOR ADVERSE CONSEQUENCES DUE TO ARCING CAUSED BY A BREACH IN INSULATION.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9310921 ↗MalfunctionNov 12, 2019Arcing
IT WAS REPORTED THAT THERE WAS A POTENTIAL FOR ADVERSE CONSEQUENCES DUE TO ARCING CAUSED BY A BREACH IN INSULATION.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9310914 ↗MalfunctionOct 21, 2019Break; Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT SHEATH BROKE INSIDE PATIENT. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9214837 ↗MalfunctionAug 22, 2019Arcing; Excessive Heating; Excessive Heating
IT WAS ALLEGED THAT THE SPATULA WAS SLIGHTLY COVERED BY THE SHEATH CAUSING THE DEVICE TO ARC. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8921056 ↗MalfunctionAug 22, 2019Overheating of Device; Arcing; Overheating of Device
IT WAS REPORTED THAT THE SPATULA WAS SLIGHTLY COVERED BY THE SHEATH CAUSING THE DEVICE TO ARC. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8921055 ↗MalfunctionAug 22, 2019Arcing; Excessive Heating; Excessive Heating
IT WAS ALLEGED THAT THE SPATULA WAS SLIGHTLY COVERED BY THE SHEATH CAUSING THE DEVICE TO ARC. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8921053 ↗MalfunctionAug 22, 2019Overheating of Device; Arcing; Overheating of Device
IT WAS ALLEGED THAT THE SPATULA WAS SLIGHTLY COVERED BY THE SHEATH CAUSING THE DEVICE TO ARC. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8920888 ↗MalfunctionAug 19, 2019Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS A BREACH IN THE INSULATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8906276 ↗MalfunctionMay 20, 2019Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PRODUCT LENGTH WAS INCORRECT, WHICH COULD CAUSE A BREACH IN INSULATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8625006 ↗MalfunctionMay 2, 2019Melted
IT WAS REPORTED THAT THE TIP OF THE INSULATION WAS MELTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8576144 ↗MalfunctionMay 2, 2019Melted
IT WAS REPORTED THAT THE TIP OF THE INSULATION WAS MELTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8576143 ↗MalfunctionMay 2, 2019Melted
IT WAS REPORTED THAT THE TIP OF THE INSULATION WAS MELTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8576142 ↗MalfunctionMay 2, 2019Melted
IT WAS REPORTED THAT THE TIP OF THE INSULATION WAS MELTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8576141 ↗MalfunctionMay 2, 2019Melted
IT WAS REPORTED THAT THE TIP OF THE INSULATION WAS MELTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8576139 ↗MalfunctionMay 2, 2019Melted
IT WAS REPORTED THAT THE TIP OF THE INSULATION WAS MELTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8576123 ↗MalfunctionMay 2, 2019Melted
IT WAS REPORTED THAT THE TIP OF THE INSULATION WAS MELTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8576122 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K963765. One submission often covers many models, so check the product and lot details in each record.
- Z-1508-2020 · Sep 12, 2019 · TerminatedStryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the followi
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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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