NA 0203030000Recalls & reported problems
Stryker Corporation · Dual Irrigation Adaptor · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540184399), received between Jul 29, 2019 and Apr 24, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Delivered as Unsterile Product2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16801610 ↗MalfunctionJul 29, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED BY THE USER FACILITY THAT THERE WAS A BLACK MATERIAL ON THE TUBE DURING PREPARATION OF A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8837172 ↗
Other LAVAGE, JET devices
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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