FlowPort CAT02439Recalls & reported problems
Stryker Corporation · FlowPort II Cannula with Obturator, Arthrex · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327405866), received between Dec 21, 2023 and May 9, 2025 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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.
Reports received per month
Most reported problems
Device problems
- Fracture7
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Scar Tissue2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2025Fracture; Fracture
IT WAS REPORTED THAT THE FLOWPORT BROKE WHEN TRYING TO ACCESS THE JOINT. NOTHING WAS LEFT IN THE PATIENT. EVERYTHING WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21998183 ↗MalfunctionApr 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE RING ON THE CANNULA FELL OFF AND THE CANNULA WAS STUCK IN THE PATIENT AND HAD TO BE MANUALLY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21820321 ↗MalfunctionApr 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE RING ON THE CANNULA FELL OFF AND THE CANNULA WAS STUCK IN THE PATIENT AND HAD TO BE MANUALLY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21819791 ↗MalfunctionJun 28, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19638096 ↗InjuryApr 25, 2024Fracture; Fracture
IT WAS REPORTED THAT A FLOWPORT CANNULA BROKE OFF AT THE DISTAL TIP WHERE THE METAL MOVES TO POLYMER. IT WAS UPON INSERTION INTO THE JOINT SPACE, THE BROKEN PORTION GOT STUCK IN THE JOINT SPACE. AFTER TRYING TO REMOVE FOR OVER 30 MIN, THE DECISION WAS MADE TO CONVERT TO AN OPEN PROCEDURE FROM A SCOPE. THE PROCEDURE WAS DELAYED 2.5 HOURS AND PATIENT HAD MORE TIME UNDER ANESTHESIA AND A LARGER SCAR.
Patient problems: Scar Tissue
MAUDE report 19188251 ↗InjuryApr 25, 2024Fracture; Fracture
IT WAS REPORTED THAT A FLOWPORT CANNULA BROKE OFF AT THE DISTAL TIP WHERE THE METAL MOVES TO POLYMER. IT WAS UPON INSERTION INTO THE JOINT SPACE, THE BROKEN PORTION GOT STUCK IN THE JOINT SPACE. AFTER TRYING TO REMOVE FOR OVER 30 MIN, THE DECISION WAS MADE TO CONVERT TO AN OPEN PROCEDURE FROM A SCOPE. THE PROCEDURE WAS DELAYED 2.5 HOURS AND PATIENT HAD MORE TIME UNDER ANESTHESIA AND A LARGER SCAR.
Patient problems: Scar Tissue
MAUDE report 19188044 ↗MalfunctionDec 21, 2023Fracture; Fracture
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18374810 ↗
Other Accessories, arthroscopic devices
- Arthrex® AR-12990Arthrex, Inc. · Accessories, arthroscopic409 reports
- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
- FIRSTPASS 72290128Smith & Nephew, Inc. · ACCESSORIES,ARTHROSCOPIC232 reports
- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.