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ACCULIF 800247Recalls & reported problems

Stryker Corporation · SYRINGE BODY · Class 2

All models of ACCULIF (15)

Data updated Oct 16, 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 07613327067118), received between Feb 12, 2016 and Feb 12, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 2026.

Most reported problems

Device problems

  • Device Operates Differently Than Expected1
  • Material Deformation1
  • Material Integrity Problem1

Patient problems

  • 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.

  • MalfunctionFeb 12, 2016Material Deformation; Material Integrity Problem; Device Operates Differently Than Expected; Material Deformation; Material Integrity Problem

    IT WAS REPORTED THAT WHEN SURGEON INITIALLY STARTED TO EXPAND THE CAGE, PRESSURE WOULD BUILD, THEN THE T-HANDLE WOULD CLICK AND THEN ALL THE PRESSURE WOULD RELEASE. O-RINGS WERE REPLACED A COUPLE OF TIMES AND THE STEPS REPEATED WITH MORE STERILE SALINE THE RESULT WAS SAME. HE BARELY GOT 1MM OF EXPANSION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5435329 ↗

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Sources and updates

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