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OASYS 48561914Recalls & reported problems

Stryker Corporation · TAP SLEEVE · Class 1

All models of OASYS (60)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327271614), received between May 9, 2017 and May 9, 2017 — classified as 1 malfunction.

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

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 18, 2026.

Most reported problems

Device problems

  • Mechanical Problem1
  • Positioning Problem1

Patient problems

  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMay 9, 2017Mechanical Problem; Positioning Problem; Mechanical Problem

    IT WAS REPORTED THAT THE SPRING INSIDE TAP SLEEVE IS NOT IN PLACE AND IS IMPEDING YOU FROM PLACING THE TAP.

    Patient problems: No Information; No Known Impact Or Consequence To Patient

    MAUDE report 6554084 ↗

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Sources and updates

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