ARROW IPN033036Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00801902096333), received between Mar 5, 2021 and Feb 25, 2026 — classified as 1 death, 69 malfunctions.

The most frequently reported specific device problem is “Crack” (33 reports).

4 other recalls cover devices cleared under the same FDA submission (K111117); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT: "THE GREEN COMPRESSION SLEEVE WAS EXCESSIVELY LOOSE AND WOULD SLIDE ONTO THE SCREW THREAD TOGETHER WITH THE JUNCTION DURING NUT TIGHTENING, WHICH CAUSED LOOSENING AND AIR ENTRAINMENT DURING BLOOD SAMPLING. THE ISSUE WAS RESOLVED ONLY AFTER THE SLEEVE WAS TRIMMED TO A SHORTER LENGTH TO ENABLE SUBSEQUENT OPERATION. AFTER CONFIRMED WITH THE CUSTOMER, 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 24441408 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT: "ON (B)(6) 2026, THE DOCTOR FOUND PATIENT'S TUNNELED CATHETER BLEEDING. THE LUER HUB/FITTING HAS CRACK AND THE BLEEDING IS A DIFFERENT DEFECT." ASSOCIATED COMPLAINTS: 9680794-2026-00111 AND 9680794-2026-00110.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363194 ↗
• MalfunctionFeb 12, 2026Crack

  IT WAS REPORTED THAT: "(B)(6) 2026, THE LUER HUB WAS FOUND CRACKED DURING USE ON THE PATIENT. THE INSERTION DATE IS ON (B)(6) 2025, THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320509 ↗
• MalfunctionJan 2, 2026Crack

  IT WAS REPORTED THAT: "(B)(6) 2025, (B)(6), THE RED LUER HUB WAS FOUND CRACKED DURING USE ON THE PATIENT. THE PATIENT WAS REPORTED AS BEING FINE POST THE PROCEDURE. THERE WAS NO HARM OR CONSEQUENCE, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. INVOLVED 1 PC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942782 ↗
• MalfunctionDec 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "ONE HALF OF THE INTRODUCER SHEATH'S HEMOSTATIC VALVE COMPLETELY DETACHED DURING CATHETER INSERTION, HAVING BEEN PUSHED INTO THE SHEATH BETWEEN THE TWO BRANCHES. SINCE THIS HALF WAS NO LONGER VISIBLE, AND THERE WAS A RISK OF THIS STRUCTURE ENTERING THE BLOODSTREAM IF WE CONTINUED INSERTING THE CATHETER, IT WAS NECESSARY TO REMOVE THE CATHETER, REMOVE HALF OF THE HEMOSTATIC VALVE, AND REINSERT THE CATHETER. THERE WERE NO IMMEDIATE COMPLICATIONS, SUCH AS BLEEDING OR AIR EMBOLISM, AND THE FACT THAT PART OF THE CATHETER WAS ALREADY INSIDE THE SHEATH PREVENTED BLOOD FROM LEAKING. THE PATIENT WAS REPROTED AS FINE PSOT THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713583 ↗
• MalfunctionSep 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "ONE HALF OF THE INTRODUCER SHEATH'S HEMOSTATIC VALVE COMPLETELY DETACHED DURING CATHETER INSERTION, HAVING BEEN PUSHED INTO THE SHEATH BETWEEN THE TWO BRANCHES." IT WAS NECESSARY TO EXTERIORIZE THE CATHETER, REMOVE HALF OF THE HEMOSTATIC VALVE, AND REINSERT THE CATHETER." THE USER CHANGED TO A NEW SHEATH. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 23166473 ↗
• MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "ONE HALF OF THE INTRODUCER SHEATH'S HEMOSTATIC VALVE COMPLETELY DETACHED DURING CATHETER INSERTION, HAVING BEEN PUSHED INTO THE SHEATH BETWEEN THE TWO BRANCHES. SINCE THIS HALF WAS NO LONGER VISIBLE, AND THERE WAS A RISK OF THIS STRUCTURE ENTERING THE BLOODSTREAM IF WE CONTINUED INSERTING THE CATHETER, IT WAS NECESSARY TO EXTERIORIZE THE CATHETER, REMOVE HALF OF THE HEMOSTATIC VALVE, AND REINSERT THE CATHETER. THERE WERE NO IMMEDIATE COMPLICATIONS, SUCH AS BLEEDING OR AIR EMBOLISM, AND THE FACT THAT PART OF THE CATHETER WAS ALREADY INSIDE THE SHEATH PREVENTED BLOOD FROM LEAKING." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727174 ↗
• DeathAug 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT "INCIDENT INVOLVED A 85-YEAR-OLD PATIENT WHO HAS BEEN ON DIALYSIS SINCE (B)(6) 2024 FOR STAGE V CHRONIC KIDNEY DISEASE. ON (B)(6) 2025, 15 MINUTES AFTER THE START OF THE DIALYSIS SESSION, THE PATIENT SUDDENLY LOST CONSCIOUSNESS WITH A GLASGOW COMA SCALE SCORE OF 8 AND A DROP IN BLOOD PRESSURE TO 79/55 MMHG. THERE WAS NO "AIR BUBBLE" ALARM ON THE GENERATOR, WHICH WOULD NOT HAVE DETECTED THE PRESENCE OF AIR IN THE LINE, DUE TO A GENERATOR MALFUNCTION OR AIR ENTERING BEFORE THE DETECTOR. PATIENT WAS TRANSFERRED TO INTENSIVE CARE FOR SUSPECTED GAS EMBOLISM, HE WAS INTUBATED, VENTILATED. A HYPERBARIC CHAMBER SESSION WAS PERFORMED. THE ELECTROCARDIOGRAM PERFORMED ON (B)(6) REVEALED GENERALIZED CEREBRAL DAMAGE IN THE CONTEXT OF A STROKE DUE TO PROBABLE GAS EMBOLISM. THE PATIENT DIED ON (B)(6) 2025." ASSOCIATE MDR NUMBERS INCLUDE: 3006425876-2025-00715.

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension; Stroke/CVA

  MAUDE report 22699014 ↗
• MalfunctionJun 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "THE COMPRESSION SLEEVES THAT ARE SUPPOSED TO SLIDE OVER THE CATH ARE SPLITTING. IT WAS THOUGHT TO BE A RANDOM ISSUE, BUT IT HAS HAPPENED A COUPLE TIMES NOW WITH THE DOCTOR. IT HAPPENED TODAY IN THE CASE AND HE HAD TO OPEN ANOTHER BOX JUST FOR THE GREEN SLEEVES. THIS HAS HAPPENED TO TWO OTHER KITS TO GET A GREEN COMPRESSION SLEEVE THAT WOULD WORK. TOTAL OPENED 3 KITS FOR ONE PATIENT." ADDITIONAL INFORMATION RECEIVED CLARIFIES THE DEVICE SPLIT ONCE IT WAS OPENED SO ANOTHER KIT WAS REQUIRED. THE SUBSEQUENT DEVICE SPLIT AS WELL AND SECOND KIT WAS REQUIRED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00469, 9680794-2025-00470, AND 9680794-2025-00471.

  Patient problems: Insufficient Information

  MAUDE report 22212346 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "INCIDENT OCCURRED ON (B)(6) 2025. THERE WAS A LEAK ISSUE AT THE JUNCTURE HUB. THE SURGEON ASKED FOR ANOTHER CATHETER, TO CHANGE THIS PART, THE NEW DEVICE WAS NOT LEAKING. CONSEQUENCE WERE OPENING ANOTHER CATHETER TO CHANGE A PART AND AN EXTENDED TIME OF PROCEDURE." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203866 ↗
• MalfunctionJun 13, 2025Crack; Crack

  IT WAS REPORTED "(B)(6) 2025, THE LUER HUB/FITTING HAS A 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". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00317, 9680794-2025-00316, AND 9680794-2025-00518.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203690 ↗
• MalfunctionJun 13, 2025Crack; Crack

  IT WAS REPORTED "(B)(6) 2025, THE LUER HUB/FITTING HAS A 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". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00519, 9680794-2025-00317, 9680794-2025-00316.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203604 ↗
• MalfunctionJun 13, 2025Crack; Crack

  IT WAS REPORTED "(B)(6) 2025, THE LUER HUB/FITTING HAS CRACK DURING USED 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". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00328 AND 9680794-2025-00505.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203443 ↗
• MalfunctionJun 13, 2025Crack; Crack

  IT WAS REPORTED "(B)(6) 2025, THE 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". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00327, 9680794-2025-00504, 9680794-2025-00503, AND 9680794-2025-00502.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203401 ↗
• MalfunctionJun 13, 2025Crack; Crack

  IT WAS REPORTED "(B)(6) 2025, THE 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". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00328, 9680794-2025-00506.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203398 ↗
• MalfunctionJun 13, 2025Crack; Crack

  IT WAS REPORTED " ON (B)(6) 2025, THE 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". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00327, 9680794-2025-00504, 9680794-2025-00503, AND 9680794-2025-00502.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203381 ↗
• MalfunctionJun 13, 2025Crack; Crack

  IT WAS REPORTED "28 MAR 2025, THE LUER HUB/FITTING HAS CRACK DURING USED 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". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00327, 9680794-2025-00504, 9680794-2025-00503.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203371 ↗
• MalfunctionJun 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "THE COMPRESSION SLEEVES THAT ARE SUPPOSED TO SLIDE OVER THE CATH ARE SPLITTING. IT WAS THOUGHT TO BE A RANDOM ISSUE, BUT IT HAS HAPPENED A COUPLE TIMES NOW WITH THE DOCTOR." ANOTHER KIT WAS USED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00469, 9680794-2025-00470, AND 9680794-2025-00471, AND 9680794-2025-00553.

  Patient problems: Insufficient Information

  MAUDE report 22176201 ↗
• MalfunctionJun 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "THE COMPRESSION SLEEVES THAT ARE SUPPOSED TO SLIDE OVER THE CATH ARE SPLITTING. IT WAS THOUGHT TO BE A RANDOM ISSUE, BUT IT HAS HAPPENED A COUPLE TIMES NOW WITH THE DOCTOR." ANOTHER KIT WAS REQUIRED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00469, 9680794-2025-00470, AND 9680794-2025-00471, AND 9680794-2025-00553.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176136 ↗
• MalfunctionJun 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "THE COMPRESSION SLEEVES THAT ARE SUPPOSED TO SLIDE OVER THE CATH ARE SPLITTING. IT WAS THOUGHT TO BE A RANDOM ISSUE, BUT IT HAS HAPPENED A COUPLE TIMES NOW WITH THE DOCTOR. IT HAPPENED TODAY IN THE CASE AND HE HAD TO OPEN ANOTHER BOX JUST FOR THE GREEN SLEEVES. THIS HAS HAPPENED TO TWO OTHER KITS TO GET A GREEN COMPRESSION SLEEVE THAT WOULD WORK. TOTAL OPENED 3 KITS FOR ONE PATIENT." ADDITIONAL INFORMATION RECEIVED CLARIFIES THE DEVICE SPLIT ONCE IT WAS OPENED SO ANOTHER KIT WAS REQUIRED THE SUBSEQUENT DEVICE SPLIT AS WELL AND SECOND KIT WAS REQUIRED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00469, 9680794-2025-00470, AND 9680794-2025-00471, AND 9680794-2025-00553.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176123 ↗
• MalfunctionJun 9, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "WE CAN SEE THE JUNCTURE HUB LEAK 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 22166348 ↗
• MalfunctionMay 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "ONE HALF OF THE INTRODUCER SHEATH'S HEMOSTATIC VALVE BECAME COMPLETELY DETACHED WHEN THE CATHETER WAS INSERTED, HAVING BEEN PUSHED BY THE CATHETER TIP. SINCE THIS HALF WAS NO LONGER VISIBLE, AND THERE WAS A RISK OF THIS STRUCTURE ENTERING CIRCULATION IF WE CONTINUED INTRODUCING THE CATHETER, IT WAS NECESSARY TO REMOVE THE SHEATH AND INTRODUCE A NEW INTRODUCER SHEATH. WITHOUT IMMEDIATE COMPLICATIONS, PARTICULARLY HEMORRHAGIC COMPLICATIONS, THE FACT THAT PART OF THE CATHETER WAS ALREADY INSIDE THE SHEATH DID NOT ALLOW BLOOD TO LEAK OUT." 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 21976569 ↗
• MalfunctionApr 16, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED " ON (B)(6) 2025, THE DOCTOR FOUND THE PINCH CLAMP DOES NOT OCCLUDE 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 21846631 ↗
• MalfunctionApr 14, 2025Crack; Crack

  IT WAS REPORTED "ON (B)(6) 2025, THE LUER HUB/FITTING HAS A 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". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00328, 9680794-2025-00506, AND 9680794-2025-00505.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832565 ↗
• MalfunctionApr 14, 2025Crack; Crack

  IT WAS REPORTED "(B)(6) 2025, THE LUER HUB/FITTING HAS A 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 21832509 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111117. One submission often covers many models, so check the product and lot details in each record.

• Z-2158-2026 · Apr 10, 2026 · Open, Classified
  Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter w
• Z-2159-2026 · Apr 10, 2026 · Open, Classified
  NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep A
• Z-2156-2026 · Apr 10, 2026 · Open, Classified
  Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
• Z-1007-2015 · Feb 4, 2013 · Terminated
  The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX