ARROW IPN032944Recalls & reported problems
Teleflex Incorporated · Cannon Catheter(R) II Plus Replacement Hub Set Fits 15 Fr. x 19 cm Models · Class 2 · Implant
Quick summary
This Arrow Cannon Catheter II Plus replacement hub set is used for repairing hemodialysis catheters. The 31 reports mostly describe the Luer hub or fitting cracking during use on a patient, along with a leaking extension line and some material deformation, with staff swapping in a new set each time. There were no deaths and no injuries, and no recalls name this device. Reporting dropped sharply, from 19 in the previous 12 months to none in the most recent 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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801902096111), received between Sep 13, 2023 and Oct 20, 2025 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Crack” (27 reports).
2 other recalls cover devices cleared under the same FDA submission (K020430); they may or may not involve this specific model.
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
- Crack27
- Leak/Splash2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions31
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2025Crack; Crack
IT WAS REPORTED THAT" (B)(6) 2025, THE DOCTOR FOUND LUER HUB/FITTING HAS CRACK DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23335128 ↗MalfunctionOct 20, 2025Crack; Crack
IT WAS REPORTED THAT 23 SEP 2025, THE DOCTOR FOUND LUER HUB/FITTING HAS CRACK DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23335106 ↗MalfunctionMay 7, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED "(B)(6) 2025, THE EXTENSION LINE WAS FOUND LEAKING DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21975902 ↗MalfunctionMar 26, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21698167 ↗MalfunctionMar 11, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT." THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21573501 ↗MalfunctionMar 7, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT.". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00204 .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21546362 ↗MalfunctionMar 7, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT.". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00205.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21546352 ↗MalfunctionFeb 28, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT.". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21490374 ↗MalfunctionFeb 19, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21410319 ↗MalfunctionJan 23, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00054.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21217312 ↗MalfunctionJan 23, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21217232 ↗MalfunctionJan 8, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LURE HUB/FITTING HAS CRACK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR NUMBERS ARE 9680794-2025-00030, 9680794-2025-00031, 9680794-2025-00032, 9680794-2025-00029.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21102133 ↗MalfunctionJan 8, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LURE HUB/FITTING HAS CRACK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR NUMBERS ARE 9680794-2025-00030, 9680794-2025-00031, 9680794-2025-00032 AND 9680794-2025-00029.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21101988 ↗MalfunctionJan 8, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LURE HUB/FITTING HAS CRACK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR NUMBERS ARE 9680794-2025-00031, 9680794-2025-00032, 9680794-2025-00029.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21101933 ↗MalfunctionJan 8, 2025Crack; Crack
IT WAS REPORTED THAT "THE DOCTOR FOUND THE LURE HUB/FITTING HAS CRACK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR NUMBERS ARE 9680794-2025-00030, 9680794-2025-00031, 9680794-2025-00032 AND 9680794-2025-00029.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21101874 ↗MalfunctionDec 10, 2024Crack; Crack
IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE LUER HUB/FITTING HAS A CRACK DURING USE ON THE PATIENT. THEY CHANGED TO A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20894367 ↗MalfunctionNov 27, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE EXTENSION LINE LEAK DURING USE ON THE PATIENT." THE OPERATOR CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20800176 ↗MalfunctionNov 25, 2024Crack; Crack
IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USE ON THE PATIENT." THE OPERATOR CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20772438 ↗MalfunctionNov 6, 2024Crack; Crack
IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE LUER HUB/FITTING HAS A CRACK DURING USE ON THE PATIENT." THE OPERATOR CHANGED TO A NEW SET. THERE WAS NO PAITENT HARM OR INJURY. NO MEDICAL INTERVENITON REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20622880 ↗MalfunctionOct 21, 2024Crack; Crack
IT WAS REPORTED THAT "ON (B)(6) 2024, THE DOCTOR FOUND THE LUER HUB/FITING HAS A CRACK DURING USE ON THE PATIENT." THE OPERATOR CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20491072 ↗MalfunctionOct 21, 2024Crack; Crack
IT WAS REPORTED THAT "ON (B)(6) 2024, THE DOCTOR FOUND THE LUER HUB/FITING HAS A CRACK DURING USE ON THE PATIENT." THE OPERATOR CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20491063 ↗MalfunctionOct 21, 2024Crack; Crack
IT WAS REPORTED THAT "ON (B)(6) 2024, THE DOCTOR FOUND THE LUER HUB/FITING HAS A CRACK DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20491042 ↗MalfunctionSep 3, 2024Material Deformation; Material Deformation
IT WAS REPORTED "THE DOCTOR FOUND THE LUER HUB DAMAGED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127895 ↗MalfunctionSep 3, 2024Material Deformation; Material Deformation
IT WAS REPORTED "THE DOCTOR FOUND THE LUER HUB DAMAGED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127710 ↗MalfunctionMar 19, 2024Crack; Crack
IT WAS REPORTED THAT: "ON (B)(6) 2022, CRACKS WERE FOUND IN THE JOINT WHEN TIGHTENING, DURING USED ON THE PATIENT. NO DANGER TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18933562 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K020430. One submission often covers many models, so check the product and lot details in each record.
- Z-2804-2020 · Jul 6, 2020 · TerminatedNextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
- Z-2802-2020 · Jul 6, 2020 · TerminatedCannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
Other Kit, repair, catheter, hemodialysis devices
- NA 8888200001Mozarc Medical US LLC · Kit, repair, catheter, hemodialysis1 death18 reports
- Catheter Repair Kit 5587000Bard Access Systems, Inc. · Kit, repair, catheter, hemodialysis4 reports
- REPAIR KIT RPK-01Medical Components, Inc. · Kit, repair, catheter, hemodialysis2 reports
- ARROW IPN032946Teleflex Incorporated · Kit, repair, catheter, hemodialysis2 reports
- ARROW IPN920485Teleflex Incorporated · Kit, repair, catheter, hemodialysis1 report
- Palindrome 8888541128Mozarc Medical US LLC · Kit, repair, catheter, hemodialysis1 report
- ARROW IPN033232Teleflex Incorporated · Kit, repair, catheter, hemodialysis1 report
- Palindrome 8888541123Mozarc Medical US LLC · Kit, repair, catheter, hemodialysis1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.