NA 0400650000Recalls & reported problems
Stryker Corporation · T4 Power Pack · Class 1
- 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 04546540152534), received between Oct 28, 2019 and Oct 28, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Overheating of Device1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2019Overheating 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 9245083 ↗
Other HELMET, SURGICAL devices
- NA 0408660000Stryker Corporation · HELMET, SURGICAL9 reports
- Flyte 0408600000Stryker Corporation · HELMET, SURGICAL4 reports
- Flyte 0408645000Stryker Corporation · HELMET, SURGICAL4 reports
- NA 0400655000Stryker Corporation · HELMET, SURGICAL3 reports
- Flyte 0408655000Stryker Corporation · HELMET, SURGICAL2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.