ARROW IPN001356Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10801902127256), received between Sep 26, 2023 and Nov 14, 2025 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K141051); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT: CATHETER-RELATED INFECTION, AND A NEW PROCEDURE WAS NEEDED TO INSERT ANOTHER CATHETER. THE CATHETER WAS COLONISED BY THE SAME BACTERIA FOR WHICH THE PATIENT HAD PREVIOUSLY BEEN TREATED. THE PATIENT IS WELL AND THERE HAVE BEEN NO REPERCUSSIONS ON HIS STATE OF HEALTH." ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: Bacterial Infection

  MAUDE report 23552226 ↗
• MalfunctionNov 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "ON (B)(6) 2025, THE CATHETER CAME OUT, BUT THE YELLOW CUFF REMAINED INSIDE THE PATIENT. THE CATHETER HAD BEEN INSERTED ON (B)(6) 2024. A SURGICAL INCISION WAS SUCCESSFULLY MADE TO REMOVE THE CUFF. THE PATIENT IS WELL AND THERE HAVE BEEN NO REPERCUSSIONS ON HIS STATE OF HEALTH." ASSOCIATED COMPLAINTS 9680794-2025-00938.

  Patient problems: Foreign Body In Patient

  MAUDE report 23520793 ↗
• MalfunctionNov 10, 2025Material Deformation; Incomplete or Inadequate Connection; Material Deformation; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT "IN TIME OF IMPLANT, PROXIMAL LOCKING SCREW WAS NOT WORKING DUE TO MALFUNCTIONING DEFECT, INSIDE THE PROXIMAL LOCKING SCREW, THE THREAD WAS DEFORMED. BLOOD LEAKAGE WAS FOUND FROM JUNCTION. WE HAD TO OPEN AN ANOTHER VECTOR-FLOW 23CM TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM, PATIENT IS ABSOLUTELY FINE AND DISCHARGED FROM HOSPITAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509665 ↗
• MalfunctionOct 8, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT "USER COMPLAINS THAT THE GREEN SEALING RING SLIDES OVER THE THREAD WHEN SCREWING AND THE SEALING RING SPLITS. THIS RESULTS IN A LEAK AT THIS SCREW CONNECTION." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00822 AND 9680794-2025-00837.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23244736 ↗
• MalfunctionOct 8, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT "USER COMPLAINS THAT THE GREEN SEALING RING SLIDES OVER THE THREAD WHEN SCREWING AND THE SEALING RING SPLITS. THIS RESULTS IN A LEAK AT THIS SCREW CONNECTION." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00822 AND 9680794-2025-00837.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23244721 ↗
• MalfunctionAug 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "VASCULAR SURGEON INSERTED CHRONIC DIALYSIS CATHETER, AND REALIZED CATHETER KEPT ON LEAKING AT SCREW CAP ON HUB. HE USED THE COMPRESSION SLEEVE BUT LINE LEAKED. HE INSERTED A COMPLETE NEW SET." 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 22921562 ↗
• MalfunctionAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED "DURING THE LAST INSERTION OF THIS DEVICE BY [DOCTOR], WHO WAS ALREADY INSERTING THEM AT THE HOSPITAL, THE GREEN SEAL ON THE CATHETER LINE CONNECTOR BROKE WHEN THE LINES WERE BEING ATTACHED, WITHOUT ANY ABNORMAL MANEUVERS, AND WITHOUT [DOCTOR] APPLYING ANY FORCE." THE EMERGENCY SEAL WAS USED AND THE LINES WERE FLUSHED. ADDITIONAL INFORMATION RECEIVED STATES "THE PATIENT IS CURRENTLY DOING WELL, AND THE CATHETER IS CONTINUING TO BE USED FOR HEMODIALYSIS AFTER THE SEAL HAS BEEN CHANGED."

  Patient problems: Insufficient Information

  MAUDE report 22700757 ↗
• MalfunctionJul 31, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED " ON (B)(6) 2025, THE DOCTOR FOUND THE JUNCTURE HUB NOT SCREW TIGHTENLY PRIOR TO THE 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 22676176 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "AFTER PLACEMENT OF THE CATHETER, BLOOD WAS FOUND LEAKING FROM THE CONNECTING PART OF THE JUNCTURE HUB. THEREFORE, THE CATHETER WAS REMOVED. AS THERE WAS NO OTHER KIT TO REPLACE IN THE HOSPITAL AT THAT TIME, THE PROCEDURE WAS CANCELLED. NO INJURY TO THE PATIENT OCCURRED." THERE WAS NO MEDICAL INTERVENTION THAT OCCURRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202375 ↗
• MalfunctionJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "LEAKAGE OCCURRED ON THE ARTERIAL LIMB. NO PATIENT HARM REPORTED." ADDITIONAL INFORMATION RECEIVED ON JUN 06, 2025, INDICATED THAT " THE CUSTOMER VENTED THE CONNECTOR WITH NACL BEFORE INSTALLATION AND DID NOT DETECT ANY LEAKAGE. AFTER INSTALLATION, THE CUSTOMER DETECTED A LEAK AT THE CONNECTOR BELOW THE RED CLAMP ON THE ARTERIAL LIMB. THE USER THEN TOOK THE ATTACHMENT PIECE FROM A SECOND SET AND WAS ABLE TO PLACE THE CATHETER WITHOUT ANY PROBLEMS AND HAS BEEN USING IT SINCE. THE PATIENT HAS BEEN COMING TO THE DIALYSIS DEPARTMENT REGULARLY FOR DIALYSIS SINCE THE ATTACHMENT." 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 22125359 ↗
• MalfunctionMay 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE CATHETER WAS INSERTED WITHOUT PROBLEM. HOWEVER, AFTER PLACEMENT, IT WAS FOUND KINKED BY X-RAY. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW ONE. NO INJURY TO THE PATIENT OCCURRED. THE INSERTION SITE WAS UNKNOWN." ADDITIONAL INFORMATION RECEIVED STATES "THE KINKED PART WAS THE CATHETER BODY. USUALLY, THE CATHETER CURVES WHEN BENT, BUT IT DID NOT CURVE BUT KINKED IN A CONCAVE CONDITION. THEREFORE, IT SEEMED THAT THE LUMEN COULD NOT BE SECURED AND THE BLOOD FLOW REDUCED." 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 21987303 ↗
• MalfunctionJan 3, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT "THE SEAL ON THE SMART SEAL HEMOSTATIC DIALYSIS SHEATH WAS BROKEN AND LOOSE, IT WAS FALLING APART".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067741 ↗
• MalfunctionDec 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING A PROCEDURE, THE CATHETER BROKE AND WAS NOT FUNCTIONING. THE CUSTOMER ATTEMPTED TO DISSECT AND REINSERT IT, BUT IT STILL DID NOT WORK. THIS INCIDENT MARKS THE THIRD CATHETER THAT HAS BROKEN IN A SIMILAR MANNER. THE CATHETER HAD A "KINK" ON ITS BODY; AT FIRST, IT WORKED NORMALLY, BUT AFTER ABOUT 24 HOURS, OCCLUSIONS BEGAN TO OCCUR. NO EMERGENCY TREATMENT WAS REQUIRED, EXCEPT FOR THE REPLACEMENT OF THE GIVEN CATHETER. PNEUMOTHORAX WAS PRESENT BILATERALLY, BUT CHEST DRAINAGE WAS NOT REQUIRED, AND PNEUMOTHORAX WAS "ABSORBED" SPONTANEOUSLY WITHIN 42 HOURS".

  Patient problems: Insufficient Information

  MAUDE report 21006487 ↗
• MalfunctionDec 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING A PROCEDURE, THE CATHETER BROKE AND WAS NOT FUNCTIONING. THE CUSTOMER ATTEMPTED TO DISSECT AND REINSERT IT, BUT IT STILL DID NOT WORK. THIS INCIDENT MARKS THE THIRD CATHETER THAT HAS BROKEN IN A SIMILAR MANNER. THE CATHETER HAD A "KINK" ON ITS BODY; AT FIRST, IT WORKED NORMALLY, BUT AFTER ABOUT 24 HOURS, OCCLUSIONS BEGAN TO OCCUR. NO EMERGENCY TREATMENT WAS REQUIRED, EXCEPT FOR THE REPLACEMENT OF THE GIVEN CATHETER. PNEUMOTHORAX WAS PRESENT BILATERALLY, BUT CHEST DRAINAGE WAS NOT REQUIRED, AND PNEUMOTHORAX WAS "ABSORBED" SPONTANEOUSLY WITHIN 42 HOURS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21006470 ↗
• InjuryDec 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING A PROCEDURE, THE CATHETER BROKE AND WAS NOT FUNCTIONING. THE CUSTOMER ATTEMPTED TO DISSECT AND REINSERT IT, BUT IT STILL DID NOT WORK. THIS INCIDENT MARKS THE THIRD CATHETER THAT HAS BROKEN IN A SIMILAR MANNER. THE CATHETER HAD A "KINK" ON ITS BODY; AT FIRST, IT WORKED NORMALLY, BUT AFTER ABOUT 24 HOURS, OCCLUSIONS BEGAN TO OCCUR. NO EMERGENCY TREATMENT WAS REQUIRED, EXCEPT FOR THE REPLACEMENT OF THE GIVEN CATHETER. PNEUMOTHORAX WAS PRESENT BILATERALLY, BUT CHEST DRAINAGE WAS NOT REQUIRED, AND PNEUMOTHORAX WAS "ABSORBED" SPONTANEOUSLY WITHIN 42 HOURS".

  Patient problems: Pneumothorax

  MAUDE report 20893964 ↗
• MalfunctionOct 9, 2024Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT "DURING THE INSERTION OF THE CHRONIC DIALYSIS CATHETER, A COMPLICATION OCCURRED DURING REMOVAL OF THE PEEL-AWAY SHEATH. IT REQUIRED AN INAPPROPRIATE EFFORT TO SEPARATE PEEL-AWAY SHEATH WITH NO SUCCESS. ONE BLUE SHEATH WING WAS TORN OFF. PEEL-AWAY SHEAT WAS VERY SLOWLY AND VERY CAREFULLY CUT WITH SCISSORS AND REMOVED. THE CATHETER WAS NOT DAMAGED. DOCTOR IS VERY EXPERIENCED AND PROCEDURE WAS DONE AS PER IFU." THE DEVICE WAS REMOVED AND A SECOND TRAY WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS. NO MEDICAL INTERVENTIONS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409429 ↗
• MalfunctionOct 8, 2024Material Too Rigid or Stiff; Material Separation; Sharp Edges; Material Too Rigid or Stiff; Material Separation; Sharp Edges

  IT WAS REPORTED "DURING THE INSERTION OF THE CHRONIC DIALYSIS CATHETER, A COMPLICATION OCCURRED DURING REMOVAL OF THE PEEL-AWAY SHEATH. IT REQUIRED AN INAPPROPRIATE EFFORT TO SEPARATE PEEL-AWAY SHEATH. SHEATH WAS SEPARATED VERY SLOWLY IN SMALL INTERVAL, NOT CONTINUOUSLY. BOTH PARTS OF THE SHEATH WERE STIFF AND SHARP. THE CATHETER WAS NOT DAMAGED." THE DEVICE WAS REMOVED AND A SECOND TRAY WAS USED. 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 20397588 ↗
• MalfunctionSep 24, 2024Material Separation; Material Deformation; Material Separation; Material Deformation

  IT WAS REPORTED "PEEL AWAY SHEATH NOT PEELING AWAY DURING CVC INSERTION." ADDITIONAL INFORMATION REPORTS, "THE DOCTOR SAID THE INITI ATING CRACK DID NOT BREAK BOTH SIDES OF THE PEAL-WAY SO I WAS LEFT USING FORCEPS TO FORCE IT TO PEEL." ALL PIECES OF THE PEEL AWAY SHEATH WAS REMOVED IN ENTIRETY. 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 20294873 ↗
• MalfunctionAug 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "PATIENT UNDERGONE CATHETERIZATION AND DISCHARGED FROM HOSPITAL. LATER FOUND DAMAGE IN THE CATHETER HUB PART. WHILE THEY DO THE DIALYSIS BLOOD IS LEAKING FROM THE HUB PART." ANATOMICAL INSERTION SITE OF THE DEVICE: RIGHT SIDE APPROACH DOCTOR REPLACED THE CATHETER WITH THE NEW ONE." ADDITIONAL INFORMATION WAS REPORTED FROM THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 20062711 ↗
• MalfunctionJun 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE CATHETER WAS INSERTED INTO THE PATIENT WITHOUT PROBLEM. CONFIRMING BY AN X-RAY AFTER PLACEMENT, THE CATHETER WAS FOUND KINKED. HOWEVER, THE CATHETER WAS PLACED AS IT WAS. NO INJURY TO THE PATIENT WAS REPORTED." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608698 ↗
• MalfunctionMay 14, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT "DURING THE INSERTION OF THE CATHETER, WHEN THE PEEL-AWAY SHEATH WAS BEING REMOVED, THE MEDICAL STAFF HAD TO CUT THE DISTAL TIP WITH SCISSORS TO BE ABLE TO REMOVE IT. THE INSERTION WAS COMPLETED AND NO BREACH WAS OBSERVED ON THE CATHETER INSERTED." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19307742 ↗
• MalfunctionMay 1, 2024Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED THAT "DIALYSIS CATHETER LEAKS." THE DEVICE WAS REMOVED AND A NEW REPLACEMENT HUB WAS APPLIED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219986 ↗
• MalfunctionApr 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE EXTENSION LINE WAS FOUND TO BE LEAKING DURING USE ON THE PATIENT." 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 19202065 ↗
• MalfunctionApr 1, 2024Stretched; Stretched

  IT WAS REPORTED "A BUMP WAS OBSERVED ON THE VENOUS LINE BEFORE CONNECTION." THE DEFECT WAS FOUND PRIOR TO USE. THEREFOR NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19013100 ↗
• MalfunctionMar 7, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT "DR STATES THE PEELAWAY SHEATH WAS NOT SERRATED THEREFORE COULD NOT PEEL AWAY. HE HAD TO CUT THE SHEATH TO REMOVE IT." THE PATIENT WAS REPORTED AS FINE. THERE WAS NO HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854126 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141051. One submission often covers many models, so check the product and lot details in each record.

• Z-2157-2026 · Apr 10, 2026 · Open, Classified
  Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272