FlowPort CAT01548Recalls & reported problems
Stryker Corporation · FLOWPORT II CANNULA WITH OBTURATOR STRYKER · Class 1
All models of FlowPort (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252633037), received between Nov 13, 2018 and Jun 19, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2026Fracture
IT WAS REPORTED THAT THE FLOWPORT BROKE CLEANLY IN THE MIDDLE OF THE CANNULA DURING INSERTION, AND WE SPENT APPROXIMATELY 25 MINUTES ATTEMPTING TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT. AFTER THESE FAILURES, THE SURGEON MADE THE DECISION TO ABANDON THE LABRAL REPAIR AND INSTEAD DEBRIDE AND REMOVE THE PATIENT¿S LABRUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566582 ↗MalfunctionJan 15, 2019Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. ALL PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8248405 ↗MalfunctionNov 13, 2018Break
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8066671 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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