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NA 0206500000Recalls & reported problems

Stryker Corporation · Automatic High Vacuum Foot Pump · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540039378), received between Jan 31, 2019 and Jul 13, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Decrease in Pressure” (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

  • Decrease in Pressure1
  • Insufficient Device Problem Information1
  • Material Fragmentation1

Patient problems

  • Hearing Loss1
  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • InjuryJul 13, 2023Decrease in Pressure; Insufficient Device Problem Information; Decrease in Pressure; Insufficient Device Problem Information

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE THEY MIXED AND APPLIED CEMENT IN A PATIENT ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS, BUT FOUND THE MIXING DIDN'T WORK AND CEMENT CONSISTENCY WAS NOT CORRECT. SURGEON HAD TO REMOVE ALL APPLIED CEMENT WHICH LED TO A 30 MINUTE CASE DELAY. A SECOND BATCH OF CEMENT WAS USED AND MIXED CORRECTLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17321813 ↗
  • MalfunctionJan 31, 2019Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT THE METAL VALVE ON THE END OF THE DEVICE POPPED OFF. THERE WAS NO ASSOCIATED PROCEDURE AS THE EVENT OCCURRED DURING TESTING. HOWEVER, IT WAS FURTHER REPORTED AT THE TIME THAT A NURSE WAS BEING EVALUATED FOR A POTENTIAL HEARING INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

    Patient problems: Hearing Loss; No Consequences Or Impact To Patient

    MAUDE report 8293133 ↗

Other MIXER, CEMENT, FOR CLINICAL USE devices

All MIXER, CEMENT, FOR CLINICAL USE devices →

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