ARROW IPN036738Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50801902123904), received between May 7, 2025 and May 7, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "CATHETER WAS ORIGINALLY INSERTED ON (B)(6) 2025. REMOVED (B)(6) 2025 DUE TO EXTENSION LINE LEAKING. PATIENT NOTICED PINK DISTAL LUMEN LEAKING WHEN FLUSHING THE CATHETER. LEAK NOTICED WHERE CLEAR EXTENSION TUBING MEETS THE PINK PORT. LINE EXCHANGED NEEDED. THIS WAS ORIGINALLY A TUNNELED LINE. REPLACEMENT LINE WAS TUNNELED AS WELL." 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 21977449 ↗

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-1812-2019 · Apr 23, 2019 · Terminated
  Arrow JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM
• Z-1817-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM
• Z-1814-2019 · Apr 23, 2019 · Terminated
  Arrow JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM
• Z-1815-2019 · Apr 23, 2019 · Terminated
  Arrow JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
• Z-1816-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance JACC Product Code: JRT 43541 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-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