PULSAVAC® 00-5150-486-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024375208), received between Sep 30, 2020 and Mar 2, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT IN THE OPERATING ROOM, THE INTERIOR STORAGE OF THE PRESSURE WASHER (PULSAVAC) HAS BEEN MODIFIED; THE LONG NOZZLE IS NO LONGER FIXED AND IS NOW MIXED IN WITH THE CABLES, WITH NO CAP TO HOLD IT IN PLACE. IT FELL TWICE DURING STERILIZATION, PACKAGING PROBLEM. ANOTHER DEVICE WAS USED TO COMPLETE SURGERY. THE CUSTOMER NEVER MENTIONED THAT THE DETACHED PIECE HAD COME INTO CONTACT WITH THE PATIENT BUT THAT IT HAD FALLEN FROM THE PACKAGING. THERE WAS NO MEDICAL INTERVENTION. IT WAS UNKNOWN IF THERE WAS PATIENT HARM OR SURGICAL DELAY. DUE DILIGENCE IS IN PROGRESS. TO DATE, NO NEW INFORMATION HAS BEEN RECEIVED

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482941 ↗
• MalfunctionMar 2, 2026Detachment of Device or Device Component

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482878 ↗
• MalfunctionJul 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO SURGERY, DELIVERED GOODS WERE CONTAMINATED. WHEN OPENING THE HIP KIT THE CUSTOMER NOTICED THAT THERE ARE IMPURITIES IN THE FORM OF HAIRS ON THEIR PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608818 ↗
• MalfunctionJul 11, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED UPON PRODUCT RECEIPT; THERE WAS A HAIR INSIDE WHEN OPENING THE PACKAGE AND WAS THEREFORE UNABLE TO USE THE ITEM. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478710 ↗
• MalfunctionMar 11, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO SURGERY THE PACKAGING WAS DEFECTIVE AS THE PAPER LID WAS NOT SEALED ON THE PLASTIC PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572882 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE CONNECTION OF THE PATIENT FOR A REVISION OF A DISUNITED ARTHODESIS SCAR, THE FLANGE OF THE INTERMEDIATE PIECE USED FOR SUCTION AND IRRIGATION BECAME MALADJUSTED. THERE WAS NO HARM AND THERE WAS A DELAY REPORTED SINCE THEY STATE THERE WAS A LONGER OPERATING TIME. IT WAS CONFIRMED THAT THE NOZZLE DISENGAGED FROM THE DEVICE AS SOON AS THE SURGEON ACTIVATED IT. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290637 ↗
• MalfunctionSep 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295591 ↗
• MalfunctionJul 8, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SURGERY THE INNER PRIMARY PACKAGING HAD ALREADY BEEN OPENED. THE HEAT SEAL WAS FAULTY. THERE WAS NO PATIENT IMPACT OR DELAY. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689184 ↗
• MalfunctionMay 31, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO SURGERY IT WAS OBSERVED THAT THE WHITE FIBER WIRE WHICH KEEPS THE PULSAVAC LAVAGE TUBES TOGETHER, WAS OVER THE EDGE BETWEEN THE PAPER COVER AND PLASTIC BOX. THE DEVICE WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19435968 ↗
• MalfunctionMay 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19276650 ↗
• MalfunctionMar 28, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994555 ↗
• MalfunctionNov 29, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SURGERY WHEN THE PACKAGING WAS OPENED, THERE WERE SMALL WHITE PARTICLES ATTACHED TO THE HOSE IN THE BOX. THE BOX WAS DISCARDED, AND ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT OR DELAY NOTED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229018 ↗
• MalfunctionJul 21, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370193 ↗
• MalfunctionSep 30, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING SURGERY THE PULSAVAC PLUS AC HIP KIT MALFUNCTIONED. THE CUSTOMER REPORTED THAT DURING NORMAL USE THE BLUE CLAMPS AND THE ATTACHMENT OF THE DEVICE LOOSENED. DURING THE INVESTIGATION, IT WAS DISCOVERED THAT THE CORD WAS CUT. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10608774 ↗