NA 0250040112Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327061345), received between Jul 3, 2018 and Apr 6, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Arcing” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Overheating of Device; Temperature Problem

  IT WAS REPORTED THAT WHILE USING LAPAROSCOPIC CAUTERY HOOK DURING A PROCEDURE THE PROTECTIVE SHEATH AROUND THE BASE OF THE HOOK BEGAN TO MELT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792094 ↗
• MalfunctionFeb 12, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE DEVICE ARCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368803 ↗
• MalfunctionNov 21, 2022Overheating of Device; Arcing; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT SUFFERED MINOR BURN DUE TO ARCING. THERE WAS NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn

  MAUDE report 15839524 ↗
• MalfunctionSep 24, 2022Electromagnetic Interference; Electromagnetic Interference; Arcing

  IT WAS REPORTED THAT THE PRODUCT ARCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15475446 ↗
• InjuryOct 28, 2021Excessive Heating; Adverse Event Without Identified Device or Use Problem; Excessive Heating

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A BURN DURING PROCEDURE.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 12712085 ↗
• MalfunctionOct 27, 2021Electrical Shorting; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A BURN DURING PROCEDURE.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708137 ↗
• MalfunctionSep 30, 2021Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS DAMAGED/COMPROMISED INSULATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555434 ↗
• MalfunctionNov 27, 2019Device Difficult to Maintain; Arcing; Device Difficult to Maintain

  IT WAS REPORTED THAT THERE WAS A POTENTIAL BREACH IN INSULATION WHICH COULD FURTHER RESULT IN ADVERSE CONSEQUENCES DUE TO ARCING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9385647 ↗
• MalfunctionNov 27, 2019Structural Problem; Break; Structural Problem

  IT WAS REPORTED THAT THERE WAS A POSSIBLE BREACH IN INSULATION DUE TO ALLEGED BROKEN INSULATION WHICH COULD RESULT IN ADVERSE CONSEQUENCES DUE TO ARCING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9385519 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED DURING PROCEDURE.

  Patient problems: Burn, Thermal

  MAUDE report 8946463 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED.

  Patient problems: Burn, Thermal

  MAUDE report 8655066 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SMALL SUPERFICIAL LAYER OF THE BOWEL WAS RESECTED.

  Patient problems: Tissue Damage

  MAUDE report 8432640 ↗
• InjuryJul 3, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURN DURING SURGERY.

  Patient problems: Injury

  MAUDE report 7659982 ↗

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