PULSAVAC® 00-5150-182-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · High Capacity Narrow Intramedullary Tip · Class 2
All models of PULSAVAC (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer Biomet PULSAVAC lavage tip is a jet-powered tip used to clean out the inside of a narrow intramedullary nail during orthopedic surgery. The 36 reports all describe packaging and shipping problems rather than patient issues: units arriving unsterile, arrived damaged, or with the tip caught in the sealing area. No deaths or injuries are described, and there are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00889024374966), received between Jul 27, 2021 and Apr 2, 2026 — classified as 38 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (25 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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product25
- Manufacturing, Packaging or Shipping Problem10
- Packaging Problem6
- Unsealed Device Packaging3
- Device Damaged Prior to Receipt by User1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Delivered as Unsterile Product
No additional information available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769859 ↗MalfunctionApr 2, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT OUTSIDE OF SURGERY DURING INCOMING INSPECTION THE UNIT HAD A HAIR-LIKE SUBSTANCE IN THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769853 ↗MalfunctionMar 16, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION, ON FEB 16, 2026, THE UNIT WAS FOUND TO BE NONCONFORMING AS THERE WAS A FOREIGN SUBSTANCE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604821 ↗MalfunctionOct 28, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE, THE DEVICES WERE FOUND TO BE NONCONFORMING, AND THE PRODUCT TIP WAS CAUGHT IN THE SEALING AREA. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS 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 23407994 ↗MalfunctionOct 28, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE, THE DEVICES WERE FOUND TO BE NONCONFORMING, AND THE PRODUCT TIP WAS CAUGHT IN THE SEALING AREA. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS 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 23407993 ↗MalfunctionOct 28, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE, THE DEVICES WERE FOUND TO BE NONCONFORMING, AND THE PRODUCT TIP WAS CAUGHT IN THE SEALING AREA. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS 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 23407986 ↗MalfunctionDec 2, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THERE WAS NO ADDITIONAL INFORMATION ASSOCIATED WITH THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20819313 ↗MalfunctionDec 2, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THERE WAS NO ADDITIONAL INFORMATION ASSOCIATED WITH THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20818706 ↗MalfunctionOct 30, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20571509 ↗MalfunctionOct 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE SERIOUS INJURY AND HAS NOT BEEN PREVIOUSLY REPORTED AS A SERIOUS INJURY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20406186 ↗MalfunctionOct 2, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20351701 ↗MalfunctionJun 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19561916 ↗MalfunctionSep 26, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED AS THE PACKAGING WAS FOUND TO BE WITHIN THE ACCEPTABLE CRITERIA. THIS MEDWATCH IS BEING VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17820376 ↗MalfunctionSep 26, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED AS THE PACKAGING WAS FOUND TO BE WITHIN THE ACCEPTABLE CRITERIA. THIS MEDWATCH IS BEING VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17820365 ↗MalfunctionSep 26, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED AS THE PACKAGING WAS FOUND TO BE WITHIN THE ACCEPTABLE CRITERIA. THIS MEDWATCH IS BEING VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17820294 ↗MalfunctionSep 25, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL EVENT INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17807476 ↗MalfunctionSep 25, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17807045 ↗MalfunctionSep 25, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17807037 ↗MalfunctionSep 25, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17807034 ↗MalfunctionSep 25, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17807030 ↗MalfunctionSep 25, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17807029 ↗MalfunctionAug 29, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THERE IS DEBRIS IN THE STERILE PACKAGE. THE EVENT TIMING WAS BEFORE SHIPMENT, DURING INSPECTION AT ARRIVAL. THERE IS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17644145 ↗MalfunctionAug 29, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THERE IS DEBRIS IN THE STERILE PACKAGE. THE EVENT TIMING WAS BEFORE SHIPMENT, DURING INSPECTION AT ARRIVAL. THERE IS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17643997 ↗MalfunctionAug 29, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THERE IS DEBRIS IN THE STERILE PACKAGE. THE EVENT TIMING WAS BEFORE SHIPMENT, DURING INSPECTION AT ARRIVAL. THERE IS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTIONDUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17643766 ↗MalfunctionAug 29, 2023Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE NONCONFORMING. OUR INCOMING INSPECTION TEAM MEMBER FOUND HAIR LIKE DEBRIS IN THE STERILE PACKAGE. THE EVENT OCCURRED OUTSIDE OF SURGERY. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17642757 ↗
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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