NA 5450850003Recalls & reported problems
Stryker Corporation · Disposable Tubing Set and Extender Filter Tubing · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540716200), received between Jan 29, 2019 and Oct 22, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Inability to Irrigate” (3 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.
Most reported problems
Device problems
- Inability to Irrigate3
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2021Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12680376 ↗MalfunctionJan 28, 2020Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 9636489 ↗MalfunctionJul 23, 2019Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8816435 ↗MalfunctionJan 29, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A BLACK SUBSTANCE IN THE PACKAGING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 8284720 ↗
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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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