ARROW IPN001366Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10801902127355), received between Sep 11, 2023 and Feb 3, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (7 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT "THE CUSTOMER COMPLAINS THAT THE CATHETERS ARE NO LONGER SEALED AFTER THE SEALING RING HAS BEEN OVERWRITTEN AND THE CATHETERS HAVE BEEN SCREWED TOGETHER. IT HAS BEEN FOUND THAT THE MATERIAL OF THE SEALING RING IS PROBABLY TOO BRITTLE AND IS DAMAGED WHEN THE CATHETER IS SCREWED TOGETHER. I HAVE TWO EXAMPLES THAT CLEARLY SHOW THAT THE SEALING RINGS ARE TORN". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251193 ↗
• MalfunctionFeb 3, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT "THE CUSTOMER COMPLAINS THAT THE CATHETERS ARE NO LONGER SEALED AFTER THE SEALING RING HAS BEEN OVERWRITTEN AND THE CATHETERS HAVE BEEN SCREWED TOGETHER. IT HAS BEEN FOUND THAT THE MATERIAL OF THE SEALING RING IS PROBABLY TOO BRITTLE AND IS DAMAGED WHEN THE CATHETER IS SCREWED TOGETHER". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251175 ↗
• MalfunctionDec 11, 2025Material Split, Cut or Torn; Incomplete or Inadequate Connection; Material Split, Cut or Torn; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: "THE CUSTOMER COMPLAINS THAT THE CATHETERS DONT SEALED WHEN SCREWED TOGETHER. THEY FEEL THAT THE MATERIAL OF THE SEALING RING IS BRITTLE AND IS DAMAGED WHEN THE CATHETER IS SCREWED TOGETHER. I HAVE TWO EXAMPLES THAT SHOW THAT THE RINGS ARE TORN. THERE WAS NO HARM TO THE PATIENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779838 ↗
• MalfunctionDec 11, 2025Material Split, Cut or Torn; Incomplete or Inadequate Connection; Material Split, Cut or Torn; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: "THE CUSTOMER COMPLAINS THAT THE CATHETERS DONT SEALED WHEN SCREWED TOGETHER. THEY FEEL THAT THE MATERIAL OF THE SEALING RING IS BRITTLE AND IS DAMAGED WHEN THE CATHETER IS SCREWED TOGETHER. I HAVE TWO EXAMPLES THAT SHOW THAT THE RINGS ARE TORN. THERE WAS NO HARM TO THE PATIENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777604 ↗
• MalfunctionDec 11, 2025Material Split, Cut or Torn; Incomplete or Inadequate Connection; Material Split, Cut or Torn; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: "THE CUSTOMER COMPLAINS THAT THE CATHETERS DONT SEALED WHEN SCREWED TOGETHER. THEY FEEL THAT THE MATERIAL OF THE SEALING RING IS BRITTLE AND IS DAMAGED WHEN THE CATHETER IS SCREWED TOGETHER. I HAVE TWO EXAMPLES THAT SHOW THAT THE RINGS ARE TORN. THERE WAS NO HARM TO THE PATIENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777491 ↗
• MalfunctionDec 11, 2025Material Split, Cut or Torn; Incomplete or Inadequate Connection; Material Split, Cut or Torn; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: "THE CUSTOMER COMPLAINS THAT THE CATHETERS DONT SEALED WHEN SCREWED TOGETHER. THEY FEEL THAT THE MATERIAL OF THE SEALING RING IS BRITTLE AND IS DAMAGED WHEN THE CATHETER IS SCREWED TOGETHER. I HAVE TWO EXAMPLES THAT SHOW THAT THE RINGS ARE TORN. THERE WAS NO HARM TO THE PATIENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776913 ↗
• MalfunctionDec 11, 2025Material Split, Cut or Torn; Incomplete or Inadequate Connection; Material Split, Cut or Torn; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: "THE CUSTOMER COMPLAINS THAT THE CATHETERS DONT SEAL WHEN SCREWED TOGETHER. THEY FEEL THAT THE MATERIAL OF THE SEALING RING IS BRITTLE AND IS DAMAGED WHEN THE CATHETER IS SCREWED TOGETHER. I HAVE TWO EXAMPLES THAT SHOW THAT THE RINGS ARE TORN. THERE WAS NO HARM TO THE PATIENTS."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776870 ↗
• MalfunctionFeb 12, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT "WHEN THE PHYSICIAN TRIED TO SCREW THE THREADED COMPRESSION CAP ONTO THE HUB ASSEMBLY IT WOULD NOT TIGHTEN. THE CAP TURNS AND TURNS AND DOESN'T SECURE ONTO HUB". A NEW SET WAS OPENED TO RETRIEVE THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365422 ↗
• MalfunctionJan 12, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT: DURING DIALYSIS, AIR WAS DETECTED IN THE ASPIRATION AND BLOOD LEAKAGE FROM THE LINE DURING INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501014 ↗
• MalfunctionNov 8, 2023Expiration Date Error; Adverse Event Without Identified Device or Use Problem; Expiration Date Error; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: ON THE (B)(6) 2023 A CATHETER WAS INSERTED SUCCESSFULLY INTO A PATIENT. THEY REALISED AFTER INSERTION THAT IT WAS 10 DAYS EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092422 ↗
• MalfunctionSep 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "FOLLOWING CATHETER OVER GUIDE WIRE REPLACEMENT, PATENCY OF THE CATHETER WAS CONFIRMED WITH CONTRAST UNDER VISION BY THE DOCTOR, HOWEVER, SAYS HE COULDN'T GET BLOOD BACK AS HE ASPIRATED. INSTEAD, HE WAS PULLING AIR BUT WHEN HE FLUSH WITH HEPARIN FLUSHING WAS FLOWING EASILY. THE DOCTOR REMOVED THE CATHETER." THE DEVICE WAS REMOVED AND ANOTHER BRAND OF CATHETER WAS INSERTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785962 ↗
• MalfunctionSep 11, 2023Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device

  IT WAS REPORTED THAT: "NON-OCCLUSIVE RING AND UNSCREWED OLIVE. AIR BUBBLE IN CIRCUIT AND CATHETER." THE CONNECTION WAS LEAKING AIR. THE CATHETER WAS INSERTED IN THE LEFT INTERNAL JUGULAR VEIN. NO PATIENT HARM WAS REPORTED. THE DIALYSIS PROCEDURE WAS DELAYED AND THE CATHETER WAS REMOVED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17722452 ↗

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