PULSAVAC® 00-5150-495-01Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · Class 2
All models of PULSAVAC (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024375222), received between Oct 23, 2024 and Jan 16, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Failure to Power Up1
- Inability to Irrigate1
- Powder Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2025Powder Leak; Powder Leak
IT WAS REPORTED THAT DURING INSPECTION THERE WAS BATTERY CORROSION. 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 21172080 ↗MalfunctionOct 24, 2024Inability to Irrigate; Failure to Power Up; Inability to Irrigate; Failure to Power Up
IT WAS REPORTED THAT DURING SURGERY, THE PULSE WASHING GUN WAS OPENED LN WHICH DID NOT WORK WHEN TRYING TO WASH THE JOINT. THE PULSATILE WASHING DIDN'T EVEN TURN ON. THERE WAS NO PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION. THERE WAS A 15-MINUTE SURGICAL DELAY. DURING DEVICE EVALUATION AND VISUAL INSPECTION, IT WAS DISCOVERED THAT THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20521902 ↗MalfunctionOct 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED DURING SURGERY THAT THE PRODUCT DIDN'T WORK AT ALL FROM THE BEGINNING. THERE IS NO HARM AND A 0-15 MINUTE DELAY REPORTED. DUE DILIGENCE IS COMPLETE AS THERE IS NO ADDITIONAL INFORMATION AVAILABLE. UPON INVESTIGATION, THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20517625 ↗
Other LAVAGE, JET devices
- Elefant ASP185Coloplast A/S · LAVAGE, JET260 reports
- PULSAVAC® 00-5150-475-01Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET255 reports
- PULSAVAC® 00-5150-482-00Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET197 reports
- PULSAVAC® 00-5150-475-00Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET164 reports
- Versajet 66800039Smith & Nephew Medical Limited · Lavage, Jet160 reports
- PULSAVAC® 00-5150-482-01Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET154 reports
- Surgiphor 910110Carefusion 2200, Inc · LAVAGE, JET140 reports
- Axius Blower/Mister CB-1000Maquet Cardiovascular LLC · Lavage, Jet1 recall43 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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