ARROW IPN920517Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30801902195556), received between Jun 15, 2022 and Mar 13, 2026 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-2159-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: " ON (B)(6) 2026, AN INCIDENT OCCURRED WITH 1 DEVICE. THE GREEN SEALING RING WOULD SLIDE, PREVENTING OPTIMAL TIGHTENING. THE NURSE WAS THEREFORE UNABLE TO SCREW ON THE TUBING. CLINICAL CONSEQUENCE: PROLONGED CATHETER CLAMPING TIME. CORRECTIVE ACTION TAKEN AT THE TIME: USE OF A SECOND DEVICE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588582 ↗
• DeathSep 29, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED, "DURING THE CONNECTION OF THE CATHETER TO DIALYSIS AN AIR LEAK WAS OBSERVED AT THE LEVEL OF THE CATHETER. THE DIALYSIS SESSION HAD TO BE STOPPED AND THE CATHETER REMOVED IN THE OPERATING ROOM." IT WAS REPORTED THE CATHETER WAS INSERTED ON (B)(6) 2022 AND WAS "WELL POSITIONED" AND "MONITORED BY X-RAY". THE CATHETER WAS REMOVED AND A NEW CATHETER WAS INSERTED. DIALYSIS WAS COMPLETED WITH THE NEW CATHETER. IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2022. "THE DECEASED OF THE PATIENT IS NOT LINKED TO THE CATHETER. THE INCIDENT DELAYED THE DIALYSE."

  Patient problems: Insufficient Information

  MAUDE report 15509056 ↗
• MalfunctionSep 29, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED "DURING THE CONNECTION OF THE CATHETER TO DIALYSIS AN AIR LEAK WAS OBSERVED AT THE LEVEL OF THE CATHETER. THE DIALYSIS SESSION HAD TO BE STOPPED AND THE CATHETER REMOVED IN THE OPERATING ROOM.". IT WAS REPORTED THE CATHETER WAS INSERTED ON (B)(6) 2022 AND THE CATHETER WAS "WELL POSITIONED" AND "MONITORED BY X RAY". THE CATHETER WAS REMOVED AND REPLACED. DIALYSIS WAS COMPLETED WITH A NEW CATHETER. THE PATIENT'S CONDITION IS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508358 ↗
• MalfunctionJun 15, 2022Leak/Splash; Fitting Problem; Leak/Splash; Fitting Problem

  CUSTOMER REPORTED PRIOR ISSUE OF "GREEN SEAL IS TOO LARGE. WHEN THE HUB IS TIGHTENED, THE SEAL IS PUSHED OVER THE THREAD AND LEADS TO LEAKAGE (AIR IS DRAWN DURING ASPIRATION)." NO PATIENT INFORMATION WAS AVAILABLE. IT WAS REPORTED IN EACH CASE THE ISSUE COULD BE SOLVED BY USING A REPLACEMENT HUB. IT WAS UNKNOWN HOW MANY TIMES THE ISSUE OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 14701673 ↗
• MalfunctionJun 15, 2022Leak/Splash; Fitting Problem; Leak/Splash; Fitting Problem

  IT WAS REPORTED THAT "GREEN SEAL IS TOO LARGE. WHEN THE HUB IS TIGHTENED, THE SEAL IS PUSHED OVER THE THREAD AND LEADS TO LEAKAGE (AIR IS DRAWN DURING ASPIRATION)." NO PATIENT HARM REPORTED. THE ISSUE WAS RESOLVED BY USING A REPLACEMENT HUB. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14701469 ↗

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-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-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