FlowPort CAT02438Recalls & reported problems
Stryker Corporation · FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker FlowPort II cannula is a tube used in arthroscopic hip surgery. Most of the 46 reports describe the cannula or its obturator tip breaking or cracking during a procedure, in some cases leaving a fragment inside the patient's hip that required revision surgery. There were 8 injuries and no deaths. No recalls name this device. Reports in the last 12 months (2) are far fewer than the 11 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 07613252633181), received between Jul 2, 2018 and Apr 9, 2026 — classified as 8 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Break” (26 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
- Break26
- Fracture19
- Crack2
- Material Fragmentation2
- Contamination /Decontamination Problem1
- Device Contaminated During Manufacture or Shipping1
- Material Integrity Problem1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Known Impact Or Consequence To Patient16
- Foreign Body In Patient3
- No Consequences Or Impact To Patient3
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
- Pain1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026Fracture
IT WAS REPORTED THAT WHILE INSERTING THE CANNULA INTO THE PATIENT'S HIP JOINT CAPSULE, THE CANNULA BROKE OFF INTO THE PATIENT. THE CANNULA WAS ABLE TO BE RETRIEVED BY THE SURGEON, AND IT WAS CONFIRMED NOTHING WAS STILL RETAINED IN THE PATIENT BY X-RAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24837603 ↗MalfunctionMar 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT HAD SURGERY ON (B)(6) 2026 USING STRYKER PRODUCTS. ON (B)(6) 2026, THE DOCTOR REMOVED A DISPOSABLE PIECE OF FLOWPORT CANNULA FROM THE SAME PATIENT THAT HAD BROKEN OFF AND WAS LEFT LODGED IN THE PATIENT¿S HIP. REVISION SURGERY WAS REQUIRED.
Patient problems: Foreign Body In Patient
MAUDE report 24631496 ↗MalfunctionMay 23, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PRODUCT BROKE OFF INTO THE HIP JOINT. THE BROKEN PIECE WAS NOT LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22080461 ↗InjuryMay 23, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PRODUCT BROKE OFF INTO THE HIP JOINT. ALL BUT ONE SMALL LOOSE BODY WAS REMOVED. THIS RETAINED PIECE WAS OUTSIDE THE JOINT.
Patient problems: Foreign Body In Patient
MAUDE report 22080111 ↗MalfunctionMay 22, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE OBTURATOR BROKE OFF IN THE PATIENT. THE SURGEON WAS ABLE TO REMOVE IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22074584 ↗MalfunctionMay 8, 2025Fracture; Fracture
IT WAS REPORTED THAT PART OF THE CANNULA BROKE OFF DURING SURGERY. THE BROKEN PIECE WAS UNABLE TO BE LOCATED. HOWEVER, X-RAYS WERE NEGATIVE FOR RETAINED FOREIGN BODY. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21990174 ↗MalfunctionMar 27, 2025Fracture; Product Quality Problem; Device Contaminated During Manufacture or Shipping; Fracture; Product Quality Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21712769 ↗MalfunctionMar 5, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21531973 ↗MalfunctionMar 5, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21531878 ↗InjuryFeb 26, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE FLOWPORT 165 BROKE OFF INTO JOINT DURING HIP SCOPE. A LARGER INCISION WAS NEEDED TO PULL THE BROKEN TIP OUT BUT OTHERWISE NO COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21472335 ↗MalfunctionNov 27, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20799489 ↗InjuryNov 15, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF FLOWPORT 165 BROKE OFF INSIDE HIP JOINT. WE HAD TO DO A MINI OPEN TO GET IT OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20694915 ↗MalfunctionNov 6, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20616172 ↗MalfunctionSep 25, 2024Fracture; Fracture
IT WAS REPORTED THAT FOR THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20306615 ↗InjuryAug 29, 2024Fracture; Fracture
IT WAS REPORTED THAT THE SURGEON INTRODUCED THE FLOWPORT CANNULA THROUGH HIS INCISION AND INTO THE JOINT SPACE. AS THE SAMUARI BLADE WAS INTRODUCE INTO THE CANNULA, IT WAS RETRACTED BACK IN ORDER TO CUT THE CAPSULE AND THE SURGEON NOTICED THE DISTAL LEADING PLASTIC EDGE OF THE CANNULA HAD BROKEN OFF THE METAL PORTION OF THE CANNULA. THE ARTHROSCOPY WAS CANCELLED AND THE SURGEON HAD TO PERFORM AN ARTHROTOMY TO RETRIEVE THE BROKEN PLASTIC PIECE. THE POSTED PROCEDURE HAD TO BE STOPPED AND HAS TO BE CONDUCTED AT A LATER TIME DUE TO THE ARTHROTOMY OF THE JOINT CAPSULE. THE PROCEDURE TURNED FROM AN ARTHROSCOPY TO OPEN JOINT ARTHROTOMY TO SUCCESSFULLY RETRIEVE THE BROKEN PIECE.
Patient problems: Insufficient Information
MAUDE report 20101297 ↗MalfunctionApr 10, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19084361 ↗MalfunctionFeb 21, 2024Material Fragmentation; Material Fragmentation
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 18753929 ↗MalfunctionJan 5, 2024Break; Fracture; Break; 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 18450028 ↗MalfunctionJan 4, 2024Break; Fracture; Break; 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 18448367 ↗InjurySep 8, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED DISTAL TIP OF THE CANNULA BROKE OFF, AND WAS LEFT IN THE PATIENT AFTER SURGERY, WITHOUT HIS KNOWLEDGE. THE PATIENT RETURNED TO THE SURGEON WITH PERSISTENT PAIN AND AN XRAY REVEALED THE BROKEN DISTAL TIP IN SITU. THE PATIENT HAD TO HAVE THE DISTAL TIP SURGICALLY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 17715555 ↗MalfunctionMay 22, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16980231 ↗InjuryApr 21, 2023Break; Break
IT WAS REPORTED THERE THERE WAS A CONVERSION TO OPEN SURGERY DUE TO THE TIP BREAKING DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16792145 ↗MalfunctionSep 7, 2022Break; Break
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE BROKEN TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15375337 ↗MalfunctionApr 26, 2022Break
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14215027 ↗MalfunctionMar 24, 2022Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE DEVICE BROKE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13891767 ↗
Other ACCESSORIES,ARTHROSCOPIC devices
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- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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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