PULSAVACRecalls & reported problems across all models
Zimmer Orthopaedic Surgical Products, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 899
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 18 models of PULSAVAC by Zimmer Orthopaedic Surgical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 899 adverse event reports in the FDA's MAUDE database, received between Mar 19, 2020 and Sep 30, 2026 — classified as 1 injury, 897 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (217 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PULSAVAC problems
Device problems
- Delivered as Unsterile Product217
- Inability to Irrigate175
- Battery Problem133
- Overheating of Device85
- Failure to Power Up62
- Explosion61
- Mechanical Problem48
- Activation Problem35
Patient problems
- No Clinical Signs, Symptoms or Conditions880
- Insufficient Information20
- No Consequences Or Impact To Patient9
- No Patient Involvement2
- Aspiration/Inhalation1
- Burn(s)1
- No Known Impact Or Consequence To Patient1
PULSAVAC models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PULSAVAC® 00-5150-475-01LAVAGE, JET255 reports
- PULSAVAC® 00-5150-482-00LAVAGE, JET197 reports
- PULSAVAC® 00-5150-475-00LAVAGE, JET164 reports
- PULSAVAC® 00-5150-482-01LAVAGE, JET154 reports
- PULSAVAC® 00-5150-182-00LAVAGE, JET38 reports
- PULSAVAC® 00-5150-042-00LAVAGE, JET23 reports
- PULSAVAC® 00-5150-420-00LAVAGE, JET16 reports
- PULSAVAC® 00-5150-486-01LAVAGE, JET14 reports
- PULSAVAC® 00-5150-495-00LAVAGE, JET12 reports
- PULSAVAC® 00-5150-175-00LAVAGE, JET7 reports
- PULSAVAC® 00-5150-350-00LAVAGE, JET4 reports
- PULSAVAC® 00-5150-183-00LAVAGE, JET3 reports
- PULSAVAC® 00-5150-495-01LAVAGE, JET3 reports
- PULSAVAC® 00-5150-181-00LAVAGE, JET2 reports
- PULSAVAC® 00-5150-350-01LAVAGE, JET2 reports
- PULSAVAC® 00-5150-420-01LAVAGE, JET2 reports
- PULSAVAC® 00-5150-476-01LAVAGE, JET2 reports
- PULSAVAC® 00-5150-185-00LAVAGE, JET1 report
Recent PULSAVAC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Inability to Irrigate
It was reported that during surgery brand new device did not spray water. Investigation results found the batteries had leaked electrolyte inside of the pack. There was no patient impact. Due diligence is complete.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947778 ↗MalfunctionSep 25, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903924 ↗MalfunctionSep 24, 2026Mechanical Problem
It was reported that during surgery, the unit was not working. After final investigation, battery expulsion was confirmed. There was no patient impact or delay reported. Due diligence is complete as no further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884525 ↗MalfunctionSep 24, 2026Mechanical Problem
It was reported that during surgery, the unit was not working. There were several units sent over for the same issue. There was no patient impact or delay reported. Due diligence is complete as no further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883948 ↗MalfunctionAug 27, 2026Failure to Power Up
It was reported that during surgery, the device did not spray and made an abnormal noise Battery expulsion was confirmed after final investigation was completed. There was no patient impact and a delay of unknown time occurred while looking for a second pulsavac to wash the operation site. Due diligence is complete as no additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486482 ↗MalfunctionAug 27, 2026Mechanical Problem
It was reported that during surgery, the device did not work, even the motor at all. Batteries had leaked electrolyte inside of the pack was confirmed after the investigation was completed. There was no patient impact and there is no information if a delay occurred. Due diligence is complete as no additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50485639 ↗MalfunctionAug 27, 2026Inability to Irrigate; Overheating of Device
It was reported that during surgery the device was not spraying and the battery was overheating. There was no patient impact or delay. During product evaluation it was found that the device leaked electrolyte. Due diligence is complete and there is no additional information available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50485193 ↗OtherAug 25, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439383 ↗MalfunctionAug 25, 2026Failure to Power Up; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439132 ↗MalfunctionAug 21, 2026Failure to Power Up
It was reported that during surgery the pulsavac won't turn on/respond. Investigation results found the batteries had leaked electrolyte inside of the pack. There was no patient harm. There was no medical intervention. There was no surgical delay. Due diligence is complete, there is no additional information available,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50371267 ↗MalfunctionJul 28, 2026Inability to Irrigate
It was reported that during surgery, the unit malfunctioned. It was not spraying water from the device. Battery expulsion was confirmed after final assessment. There was no patient impact or delay. Due diligence is complete as no further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058749 ↗MalfunctionJul 27, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005302 ↗MalfunctionJun 25, 2026Mechanical Problem
IT WAS REPORTED THAT DURING SURGERY, THE DEVICE/MOTOR DID NOT WORK FROM THE START OF USE. DURING PRODUCT EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. THERE WAS NO PATIENT IMPACT, BUT IT IS UNKNOWN IF THERE WAS DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25623497 ↗MalfunctionJun 24, 2026Mechanical Problem
IT WAS REPORTED THAT DURING SURGERY, THE UNIT DID NOT WORK AT ALL FROM THE START OF USE. BATTERY EXPULSION WAS CONFIRMED AFTER FINAL ASSESSMENT. THERE WAS NO PATIENT IMPACT AND IT IS UNKNOWN IF A DELAY OCCURRED. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25616113 ↗MalfunctionJun 24, 2026Inability to Irrigate; Pressure Problem
IT WAS REPORTED THAT DURING THE SURGERY, THIS COMPLAINT PRODUCT DIDN'T SPRAY SALINE WATER ALTHOUGH THE MOTOR WAS WORKING IN HIGH MODE. BUT, THIS COMPLAINT PRODUCT ABLE TO SPRAY SALINE WATER IN LOW MODE, SO THE SURGEON COMPLETED THE SURGERY USING THIS COMPLAINT PRODUCT IN LOW MODE ONLY. A 0-15 MINUTES DELAY OCCURRED, BECAUSE THE SURGEON FINISHED THE SURGERY USING THIS COMPLAINT PRODUCT IN LOW MODE ONLY. DURING DEVICE EVALUATION, BATTERY LEAKED ELECTROLYTE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25613055 ↗
Other Zimmer Orthopaedic Surgical Products, Inc. products
All Zimmer Orthopaedic Surgical Products, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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