FlowPort CAT01549Recalls & reported problems
Stryker Corporation · FLOWPORT II CANNULA WITH OBTURATOR LINVATEC AND STORZ · 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 07613252633051), received between Oct 1, 2019 and Dec 23, 2024 — 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
- Material Integrity Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2024Fracture; Fracture
IT WAS REPORTED THAT THE SURGERY WAS EXECUTED WITH NO ISSUE OR AWARENESS THAT ANYTHING HAD MALFUNCTIONED. AT PATIENT'S FOLLOW UP, X-RAYS WERE TAKEN AND WHAT WE BELIEVE IS A BROKEN OFF PIECE OF A FLOWPORT CANNULA IS STILL IN PATIENT. PATIENT BEING BROUGHT BACK TO OR TO EXTRACT FOREIGN OBJECT.
Patient problems: Foreign Body In Patient
MAUDE report 21000515 ↗MalfunctionMar 16, 2021Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. THE TIP WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11499059 ↗InjuryOct 1, 2019Break
IT WAS REPORTED THAT THE DEVICE BROKE IN THE JOINT AND THE SURGEON CONVERTED TO OPEN PROCEDURE TO REMOVE THE TIP.
Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient
MAUDE report 9140211 ↗
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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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