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Stryker SmartLife 7212000000Recalls & reported problems

Stryker Corporation · Battery Pack, Small · Class 1

All models of Stryker SmartLife (3)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540640277), received between Oct 29, 2018 and Oct 29, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 reports).

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

  • Overheating of Device2
  • Fracture1

Patient problems

  • No Patient Involvement2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 29, 2018Overheating of Device; Overheating of Device

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Patient problems: No Patient Involvement

    MAUDE report 8014608 ↗
  • MalfunctionOct 29, 2018Fracture; Overheating of Device; Fracture; Overheating of Device

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED AND FRACTURED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Patient problems: No Patient Involvement

    MAUDE report 8014445 ↗

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Sources and updates

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