ARROW IPN033108Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20801902096634), received between Jun 1, 2021 and Jan 29, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 10, 2026Open, Classified

   16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

   Z-2158-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED 'HUB WAS NOT SCREWING ON TO THE CATHETER'. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264801 ↗
• MalfunctionNov 26, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED "R TOLD ME THEY ATTEMPTED TO TWIST THE HUB TO LOT AND IT WOULD NOT LOCK, THEY HAD TO OPEN A 2ND KIT." 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 20781775 ↗
• MalfunctionSep 13, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED "WE HAD A HUB ASSEMBLY ON A ARROW CANNON 2 PLUS HEMODIALYSIS CATHETER THAT WOULD NOT CONNECT TO THE CATHETER. WE HAD TO USE A WHOLE NEW CATHETER TO COMPLETE THE PROCEDURE." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212008 ↗
• MalfunctionMay 7, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT: "THE SHEATH WILL NOT PEEL APART AND THE DOCTORS ARE HAVING TO PULL IT OUT AND CUT IT JUST TO GET IT OUT. WE COMPLETED THE CASE AND PLACED THE CANNON CATHETER THEY JUST HAD TO CUT THE SHEATH AND DO SOME PULLING AND PUSHING TO GET IT PLACED. THE PATIENT DID WELL DURING AND AFTER THE PROCEDURE IT JUST TOOK MORE TIME AND ADDED SOME FRUSTRATION TO THE DOCTOR." ASSOCIATED COMPLAINTS: 9680794-2024-00492, 9680794-2024-00493 AND 9680794-2024-00491.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257621 ↗
• MalfunctionMay 7, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT: "THE SHEATH WILL NOT PEEL APART AND THE DOCTORS ARE HAVING TO PULL IT OUT AND CUT IT JUST TO GET IT OUT. WE COMPLETED THE CASE AND PLACED THE CANNON CATHETER THEY JUST HAD TO CUT THE SHEATH AND DO SOME PULLING AND PUSHING TO GET IT PLACED. THE PATIENT DID WELL DURING AND AFTER THE PROCEDURE IT JUST TOOK MORE TIME AND ADDED SOME FRUSTRATION TO THE DOCTOR." ASSOCIATED COMPLAINTS: 9680794-2024-00492, 9680794-2024-00493 AND 9680794-2024-00491.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257609 ↗
• MalfunctionMay 7, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT: "THE SHEATH WILL NOT PEEL APART AND THE DOCTORS ARE HAVING TO PULL IT OUT AND CUT IT JUST TO GET IT OUT. WE COMPLETED THE CASE AND PLACED THE CANNON CATHETER THEY JUST HAD TO CUT THE SHEATH AND DO SOME PULLING AND PUSHING TO GET IT PLACED. THE PATIENT DID WELL DURING AND AFTER THE PROCEDURE IT JUST TOOK MORE TIME AND ADDED SOME FRUSTRATION TO THE DOCTOR." ASSOCIATED COMPLAINTS: 9680794-2024-00492, 9680794-2024-00493 AND 9680794-2024-00491.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257586 ↗
• MalfunctionJun 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED WHEN REMOVING THE CATHETER, THE CUFF WAS NO LONGER ATTACHED TO THE CATHETER. THE PHYSICAN WAS CHANGING OUT THE CATHETER AND USUALLY DOES DISSECTION BETWEEN THE CUFF AND THE TISSUES. IN THIS CASE NOT MUCH DISSECTION HAD TO BE DONE AND THE CATHETER WAS CLEAN WITH NO RESIDUE OF THE CUFF LEFT ON IT. IT WAS UNKNOWN IF THE CUFF WAS LEFT IN THE PATIENT'S BODY. THE CUFF WAS NEVER FOUND. THE CATHETER WAS PLACED ON (B)(6) 2020 AND REMOVED (B)(6) 2021. CATHETER WORKED WITH NO ISSUES DURING THAT TIME. NO MEDICAL INTERVENTION WAS REQUIRED. NO IMAGING WAS PERFORMED ON PATIENT TO LOOK FOR CUFF. NO PATIENT HARM WAS REPORTED. THE NEW CATHETER WAS PLACED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913948 ↗

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-2156-2026 · Apr 10, 2026 · Open, Classified
  Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
• 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-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