ARROW IPN001181Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902112726), received between Jun 22, 2023 and Dec 17, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2024Break; Break

  IT WAS REPORTED "DOCTOR CALLED TO SAY THERE WAS AN ISSUE WITH THE PRODUCT. I HAVE COLLECTED THE SAMPLE AND NOTICE THE DILATOR TIP IS FRACTURED. DR COULD NOT SPEAK TO ME REGARDING HOW THE DILATOR TIP BROKE." 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 20951515 ↗
• MalfunctionJul 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE PHYSICIAN PLACED A 55 CM CHRONIC DIALYSIS SET OF VECTORFLOW RANGE ON A PATIENT VIA FEMORAL ACCESS SITE AND AFTER HUB CONNECTION WAS DONE A LEAKAGE FROM HUB AREA WAS DETECTED WHILE TESTING THE PATENCY OF ARTERIAL AND VENOUS LINES. ADAPTOR WAS DISASSEMBLED AND RECONNECTED AND THE LEAKAGE REMAINED. ANOTHER SET WAS OPENED (SAME PRODUCT CODE) AND THE HUB WAS REPLACED WITH NO LEAKAGE. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286656 ↗
• MalfunctionJun 22, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE SURGEON PLACED THE CATHETER ON A PATIENT VIA FEMORAL ACCESS SITE AND AFTER HUB CONNECTION WAS DONE THERE WAS A LEAKAGE FROM THE HUB AREA WHILE TESTING THE PATENCY OF THE ARTERIAL AND VENOUS LINES. THE CATHETER WAS LEFT IN SITU AND THE HUB WAS REPLACED. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184755 ↗

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