Strykeprobe 0250070441Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327051865), received between Oct 3, 2018 and Jun 17, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K934094); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2024Thermal Decomposition of Device; Temperature Problem; Thermal Decomposition of Device; Temperature Problem

  IT WAS REPORTED THAT THERE WAS DAMAGED/COMPROMISED INSULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19553570 ↗
• MalfunctionJun 17, 2024Material Fragmentation; Temperature Problem; Material Fragmentation; Temperature Problem

  IT WAS REPORTED THAT THERE WAS DAMAGED/COMPROMISED INSULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19553478 ↗
• MalfunctionJun 7, 2024Thermal Decomposition of Device; Temperature Problem; Thermal Decomposition of Device; Temperature Problem

  IT WAS REPORTED THAT THERE WAS DAMAGED/COMPROMISED INSULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488335 ↗
• MalfunctionAug 22, 2019Arcing; Connection Problem; Connection Problem

  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 8921054 ↗
• 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 8906278 ↗
• MalfunctionFeb 21, 2019Melted

  IT WAS REPORTED THAT THE CAUTERY TIP MELTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8360167 ↗
• MalfunctionOct 3, 2018Material Fragmentation

  IT WAS REPORTED THAT PIECES BROKE OFF INSIDE PATIENT. THE BROKEN PIECES WERE REMOVED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931303 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K934094. One submission often covers many models, so check the product and lot details in each record.

• Z-2170-2025 · Jun 18, 2025 · Open, Classified
  Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
• Z-1509-2020 · Sep 12, 2019 · Terminated
  Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the followin
• Z-0835-2018 · Nov 17, 2017 · Terminated
  StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION