Renasys 66801309Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00040565126470), received between Jul 2, 2020 and Sep 9, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Defective Alarm” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K142979); they may or may not involve this specific model.

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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2021Defective Alarm; Battery Problem; Defective Alarm; Battery Problem

  IT WAS REPORTED THAT ONE RENASYS EZ MAX HOSPITAL IS BURNT, THE ALARM DOES NOT WORK, AND THE BATTERY CANNOT CHARGE. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450689 ↗
• MalfunctionApr 27, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING SERVICE EVALUATION THE RENASYS EZ MAX DEVICE WAS FOUND UNABLE TO GENERATE AND CONTROL NEGATIVE PRESSURE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734965 ↗
• MalfunctionApr 5, 2021Defective Alarm; Component Misassembled; Defective Alarm; Component Misassembled

  IT WAS REPORTED THAT DURING THE INSPECTION OF NEW DEVICES IT WAS DETECTED THE RENASYS EZ PUMP DOESN´T ACTIVATE THE CANISTER FULL ALARM FUNCTION. IT WAS DETECTED THE PRESSURE GAUGE HOSE WAS NOT POSITIONED PROPERLY AND IT IS VERY SHORT FOR THE DISTANCE TO THE NEAREST HOSE COUPLER. NO PROCEDURE INVOLVED SINCE IT WAS A OUT OF BOX FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612276 ↗
• MalfunctionFeb 26, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE PUMP WOULD NOT SUSTAIN SUCTION. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11384808 ↗
• MalfunctionFeb 11, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING TESTING THE RENASYS UNIT HAD AN INTERMITTENT START. NO CASE INVOLVED. DURING FUNCTIONAL EVALUATION IT WAS CONFIRMED THAT THE DEVICE HAD NO SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11318748 ↗
• MalfunctionOct 28, 2020Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT BEFORE TREATMENT IT WAS FOUND THAT THE BATTERY IS NOT CHARGING. NO PATIENT INVOLVED OR INJURED. NO DELAY. BACKUP DEVICE WAS USED.

  Patient problems: No Patient Involvement

  MAUDE report 10750807 ↗
• MalfunctionOct 28, 2020Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT BEFORE TREATMENT IT WAS FOUND THAT THE BATTERY IS NOT CHARGING. NO PATIENT INVOLVED OR INJURED. NO DELAY. BACKUP DEVICE WAS USED.

  Patient problems: No Patient Involvement

  MAUDE report 10750745 ↗
• MalfunctionOct 28, 2020Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICE EVALUATION THE DEVICE WAS NOT ABLE TO GENERATE ALARMS UNDER EXPECTED ALARM CONDITIONS. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10749533 ↗
• MalfunctionOct 2, 2020Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR, THE RENASYS EZ MAX COULD NOT START UP CORRECTLY, CONTAINS CRITICAL ERRORS AND CANNOT OPERATE ON AC OR BATTERY POWER NOR RECHARGE THE BATTERY, BECAUSE THE BATTERY DOES NOT KEEP THE CHARGE, ALSO THE DEVICE FAIL TO ALARM AND IS NOISY AND VIBE; NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10623490 ↗
• MalfunctionJul 2, 2020Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DEVICE DOESN¿T ALARM WHEN BLOCKED AND RATTLE INSIDE UNIT WAS NOTICED. NO CASE INVOLVED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224723 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142979. One submission often covers many models, so check the product and lot details in each record.

• Z-2848-2016 · Jul 21, 2016 · Open, Classified
  RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction devi