ARROW IPN036736Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 60801902123888), received between Apr 29, 2025 and Apr 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K132133); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED "CLINICIAN ACCESSED VESSEL WITH INTRODUCED NEEDLE AND VISUALIZED BLOOD RETURN. WHEN ATTEMPTING TO FEED THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE IT WOULD NOT ADVANCE PAST THE FLOPPY END. INTRODUCER NEEDLE AND GUIDEWIRE HAD TO BE REMOVED FROM PATIENT AS ONE UNIT. WHEN EXAMINING THE GUIDEWIRE A 'BUR' OR 'SEAM' WAS NOTICED AND FELT AT THE FLOPPY END. AN 80CM HYDROPHILIC GUIDEWIRE WAS DROPPED SINGLE STERILE TO COMPLETE THE PROCEDURE. 2ND STICK WAS SUCCESSFUL WITH 80CM GUIDEWIRE." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00367.

  Patient problems: Insufficient Information

  MAUDE report 21926069 ↗
• MalfunctionApr 29, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED "CLINICIAN ACCESSED VESSEL WITH INTRODUCED NEEDLE AND VISUALIZED BLOOD RETURN. WHEN ATTEMPTING TO FEED THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE IT WOULD NOT ADVANCE PAST THE FLOPPY END. INTRODUCER NEEDLE AND GUIDEWIRE HAD TO BE REMOVED FROM PATIENT AS ONE UNIT. WHEN EXAMINING THE GUIDEWIRE A 'BUR' OR 'SEAM' WAS NOTICED AND FELT AT THE FLOPPY END. AN 80CM HYDROPHILIC GUIDEWIRE WAS DROPPED SINGLE STERILE TO COMPLETE THE PROCEDURE. 2ND STICK WAS SUCCESSFUL WITH 80CM GUIDEWIRE." THERE WAS NO PATINT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00367 AND 9680794-2025-00409.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925967 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132133. One submission often covers many models, so check the product and lot details in each record.

• Z-2379-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JA
• Z-1814-2019 · Apr 23, 2019 · Terminated
  Arrow JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM
• Z-1812-2019 · Apr 23, 2019 · Terminated
  Arrow JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM
• Z-1815-2019 · Apr 23, 2019 · Terminated
  Arrow JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
• Z-1806-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 44052 VPS2
• Z-1816-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM
• Z-1817-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM
• Z-2015-2018 · Apr 11, 2018 · Terminated
  ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
• Z-0207-2016 · Oct 16, 2015 · Terminated
  ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS