Strykeprobe 0250070442Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327051889), received between Dec 18, 2018 and Sep 30, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT WHILE THE DEVICE WAS BEING PULLED OUT OF THE PATIENT INTO THE SHEATH, IT BURNT THE SHEATH. THEREFORE, THERE WAS A THERMAL EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23187042 ↗
• MalfunctionDec 28, 2018Break

  IT WAS REPORTED THAT THE TIP WAS BROKEN DURING A PROCEDURE. IT WAS ALSO CONFIRMED THAT ALL PIECES WERE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8203586 ↗
• InjuryDec 18, 2018Break

  IT WAS REPORTED THAT THE SHEATH BROKE DURING A PROCEDURE AND CANNOT BE CONFIRMED THAT ALL PIECES WERE RETRIEVED.

  Patient problems: No Code Available

  MAUDE report 8177055 ↗

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