PULSAVAC® 00-5150-042-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · Dual Spike Y-Connector Set, Packaged · Class 2
All models of PULSAVAC (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer Pulsavac lavage connector set is used for surgical wound cleaning. The 23 reports mostly describe packaging and sterility issues found before use, such as hair-like material inside sterile packs and wrinkles in seals, with no deaths and no injuries. No recalls name this device. Recent reports fell to 2 from 13 in the prior period.
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
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00889024374928), received between May 8, 2023 and Feb 6, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (16 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 Product16
- Manufacturing, Packaging or Shipping Problem3
- Device Damaged Prior to Receipt by User2
- Packaging Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions23
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE DEVICE HAD A HAIR-LIKE SUBSTANCE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278622 ↗MalfunctionFeb 6, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE DEVICE HAD A HAIR-LIKE SUBSTANCE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278619 ↗MalfunctionJul 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THERE WAS A HAIR-LIKE SUBSTANCE INSIDE THE STERILE 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 22507414 ↗MalfunctionJul 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE PACKAGING HAD WRINKLES IN THE SEALING AREA. 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 22507410 ↗MalfunctionJul 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE PACKAGING HAD WRINKLES IN THE SEALING AREA. 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 22507404 ↗MalfunctionJul 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE PACKAGING HAD WRINKLES IN THE SEALING AREA. 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 22507401 ↗MalfunctionJul 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE PACKAGING HAD WRINKLES IN THE SEALING AREA. 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 22507400 ↗MalfunctionJul 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE PACKAGING HAD WRINKLES IN THE SEALING AREA. 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 22507398 ↗MalfunctionJul 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE PACKAGING HAD WRINKLES IN THE SEALING AREA. 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 22507392 ↗MalfunctionJul 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE PACKAGING HAD WRINKLES IN THE SEALING AREA. 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 22507386 ↗MalfunctionJul 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE PACKAGING HAD WRINKLES IN THE SEALING AREA. 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 22507379 ↗MalfunctionJul 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE PACKAGING HAD WRINKLES IN THE SEALING AREA. 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 22507299 ↗MalfunctionJul 14, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION A FOREIGN SUBSTANCE WAS FOUND WITHIN THE 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 22494981 ↗MalfunctionMay 20, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING INCOMING INSPECTION DEBRIS WAS FOUND IN THE STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. PER DEVICE EVALUATION, VISUAL INSPECTION CONFIRMED THERE WAS DEBRIS INSIDE THE SEALED PACKAGE OF THE CONNECTOR; THEREFORE, PACKAGING WAS NON-CONFORMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055493 ↗MalfunctionMay 20, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING INCOMING INSPECTION HAIR-LIKE DEBRIS WAS FOUND IN THE STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, AND NO ADDITIONAL INFORMATION IS AVAILABLE. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE HAIR-LIKE DEBRIS SEALED INSIDE THE STERILE PACKAGE OF THE CONNECTOR WAS LARGER THAN 5.00SQ MM. THEREFORE, PACKAGING WAS NON-CONFORMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055348 ↗MalfunctionApr 3, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19035761 ↗MalfunctionMar 12, 2024Delivered 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 18890606 ↗MalfunctionFeb 5, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THERE WAS A HAIR-LIKE SUBSTANCE IN THE PACKAGE. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18647856 ↗MalfunctionJul 28, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING INSPECTION, IT WAS FOUND THAT THERE WAS DEBRIS IN THE STERILE PACKAGING. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THERE WAS DEBRIS MEASURING .80MM SQUARED SEALED INSIDE THE STERILE PACKAGE. THIS WAS DETERMINED TO BE NON-CONFORMING. 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 17414026 ↗MalfunctionJun 20, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT AT INCOMING INSPECTION THE PRODUCT HAD HAIR LIKE DEBRIS IN THE STERILE PACKAGE. NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT EVALUATION INSPECTION THE DEBRIS WAS FOUND TO BE GREATER THAN 0.60 SQ. MM. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17161835 ↗MalfunctionJun 7, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING INSPECTION, IT WAS FOUND THAT THERE WAS DEBRIS IN THE STERILE 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 17083494 ↗MalfunctionMay 23, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING INCOMING INSPECTION ON (B)(6) 2023, HAIR LIKE DEBRIS WAS FOUND IN THE STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16983157 ↗MalfunctionMay 8, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED DURING THE INCOMING INSPECTION AT ZB WAREHOUSE IN JAPAN A TEAM MEMBER FOUND HAIR LIKE DEBRIS/DEBRIS IN THE STERILE PACKAGE. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. THE PACKAGING FOR THIS COMPLAINT PRODUCT DID NOT MEET SPECIFICATION, AS THERE WERE MORE THAN 2 LOOSE PARTICULATES FOUND. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16886207 ↗
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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