ARROW IPN036739Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50801902123911), received between Mar 22, 2024 and Jan 21, 2026 — classified as 3 malfunctions.

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

• MalfunctionJan 21, 2026Material Rupture

  IT WAS REPORTED THAT "WE HAD A PT TODAY THAT WE PLACED A JACC IN AND LINE WORKED FINE UP UNTIL THE POINT IT NEEDED TO BE POWER INJECTED. JACC WAS PLACED AT 0940. PT SENT TO CT APPROXIMATELY 1430. CT REPORTING LINE LEAKING WHEN ATTEMPTING TO POWER INJECT SALINE. PRIOR TO THIS, THE LINE WORKED FINE INCLUDING HAND INJECTING SALINE. THE FLOOR CONTACTED US AT 1514 THAT IJ IS OOZING. UPON ARRIVAL TO ROOM AT 1530 AND LINE ASSESSMENT PERFORMED, DISTAL POWER INJECTABLE LUMEN OF LINE ASPIRATES BLOOD BUT LEAKS SALINE WHEN FLUSHING. LINE DISCOVERED TO BE RUPTURED RIGHT AFTER WINGS". THE LINE WAS REMOVED AND REPLACED AS THE PATIENT WAS LEAKING BLOOD OUT OF THE HOLE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE, DOWNGRADED FROM ICU STATUS".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24130147 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: " SHEATH BROKE OFF HANDLE". POST INSERTION OF A JACC THROUGH THE SHEATH, WHEN BEGINNING TO TEAR AWAY THE SHEATH, THE WHITE "HANDLE" OR TAB TORE AWAY FROM THE REST OF THE SHEATH LEAVING ONLY THE OTHER TAB AND THE SHEATH INTACT. TO REMOVE THE SHEATH, I MANUALLY PUSHED THE CATHETER ALONG THE LINE OF THE SHEATH WHERE IT IS INTENDED TO TEAR AWAY, OPENING ONLY ONE SIDE OF THE SHEATH. THE SHEATH WAS REMOVED COMPLETELY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300457 ↗
• MalfunctionMar 22, 2024Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT: CATHETER WAS PLACED (B)(6) 2024, THEN FOUND TO BE KINKED IN THE SOFT TISSUES ON (B)(6) WITH POOR BLOOD RETURN. ONE OF THE NURSES PULLED IT BACK TO SEE IF THE KINK WOULD SMOOTH OUT AND IF THE LINE WOULD THEN WORK. AS SHE PULLED THE CATHETER BACK, SHE NOTED THE SPLIT AND REMOVED THE CATHETER. THE SPLIT IS FOUND AROUND THE 20CM MARK. PATIENT RECEIVED A NEW JACC PLACEMENT AFTER THIS CATHETER WAS REMOVED. ADDITIONAL INFORMATION: THE CATHETER WAS PLACED SATURDAY NIGHT. ON SUNDAY THE PATIENT WAS VERY AGITATED AND MOVING ALOT. NURSES HAD TO HOLD HER WHILE THEY ATTEMPTED TO GIVE IV SEDATION THROUGH THE CATHETER. THEY USED FORCE AND WERE UNSUCCESFUL, PIVS WERE INSERTED AND USED FOR SEDATION. A CHEST XRAY THEN SHOWED THAT THE LINE WAS KINKED. THE PATIENT CONDITION WAS REPORTED AS "FINE" POST-PROCEDURE. MEDICAL INTERVENTION REPORTED STATES: CATHETER NEEDED TO BE REMOVED PRIOR TO THERAPY COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957525 ↗

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