Strykeprobe 0250070453Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327051964), received between Jun 10, 2025 and Jun 10, 2025 — classified as 1 malfunction.

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

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.

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.

• MalfunctionJun 10, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE OUTER PLASTIC SHEATH BROKE INSIDE THE PATIENT'S ABDOMEN DURING SURGERY. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176144 ↗

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 · Terminated
  Stryker, 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