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NA 6370Recalls & reported problems

Stryker Corporation · Class 2

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327261622), received between Oct 26, 2018 and Jan 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated3
  • Device Fell2
  • Positioning Failure1
  • Vibration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Patient Involvement2

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 28, 2025Device Fell; Device Fell

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED THE FASTENER NO LONGER FACILITATING PROPER COT OPERATIONS DURING LOADING OR UNLOADING. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21257415 ↗
  • MalfunctionJul 18, 2024Vibration; Device Dislodged or Dislocated; Vibration; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE CUSTOMER HAS A LOCKING RAIL FOR MASS CASUALTY IN A TRANSPORT VAN THAT THE COT IS BECOMING UNLOCKED FROM ON OCCASION. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19777079 ↗
  • MalfunctionOct 24, 2022Device Fell; Device Fell

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE DID NOT FACILITATE PROPER COT OPERATIONS DURING LOADING/UNLOADING. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15659063 ↗
  • MalfunctionOct 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED THE FASTENER UNEXPECTEDLY DISENGAGING. THERE WAS PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12693772 ↗
  • MalfunctionOct 26, 2018Positioning Failure; Positioning Failure

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE COT FASTENER HAD UNINTENDED ENGAGEMENT/DISENGAGEMENT. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 8010754 ↗
  • MalfunctionOct 26, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE COT FASTENER HAD INSUFFICIENT RETENTION FORCE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 8009636 ↗

Other STRETCHER, WHEELED devices

All STRETCHER, WHEELED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.