PULSAVAC® 00-5150-183-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · High Capacity Intramedullary Brush Tip · 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 00889024374973), received between Jul 15, 2025 and Aug 11, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Delivered as Unsterile Product1
- Detachment of Device or Device Component1
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.
MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY, ON AN UNKNOWN DATE, WHILE IRRIGATING THE FEMORAL CANAL OF THE PATIENT THE END OF THE BRUSH TIP BROKE OFF INTO THE CANAL. LAPAROSCOPIC GRASPER WAS USED TO RETRIEVE THE BROKEN PIECE FROM THE CANAL. THE PATIENT DID NOT RETAIN ANY OF THE DETACHED PIECES AND ALL OF THE PIECES WERE SUCCESSFULLY RETRIEVED. IT WAS A DELAY OF UNKNOWN TIME. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777627 ↗MalfunctionJul 16, 2025Break
WHILE IRRIGATING THE FEMORAL CANAL OF THE PATIENT THE END OF THE BRUSH TIP BROKE OFF INTO THE CANAL. LAPAROSCOPIC GRASPER WAS USED TO RETRIEVE THE BROKEN PIECE FROM THE CANAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22518671 ↗MalfunctionJul 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507466 ↗
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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