Strykeprobe 0250070450Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327051926), received between Sep 17, 2019 and Sep 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2019Break

  IT WAS REPORTED THAT THE END OF SHEATH BROKE OFF INSIDE THE PATIENT. BROKEN PIECE WAS RECOVERED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9078130 ↗

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