ARROW IPN924178Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902208825), received between Apr 9, 2024 and Oct 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

11 other recalls cover devices cleared under the same FDA submission (K112896); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2370-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionOct 18, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THE PROVIDER THOUGHT THERE WAS A BURR ON THE TIP OF THE PICC LINE PRIOR TO USE ON THE PATIENT. THEY GRABBED A DIFFERENT KIT AND COMPLETED THE PROCEDURE." ADDITIONAL INFORMATION REPORTS THE DEFECT WAS FOUND "AT THE TIME OF PLACEMENT." 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 20480908 ↗
• MalfunctionApr 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED "RUPTURE OF THE PICC AT THE 1 CM MARK". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 19071696 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112896. One submission often covers many models, so check the product and lot details in each record.

• Z-2378-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR
• Z-1822-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code:PR 45552 HPHNM
• Z-1811-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
• Z-1819-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code: PR 45541 HPHNL
• Z-1820-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
• Z-1327-2018 · Dec 22, 2017 · Terminated
  Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
• Z-0996-2018 · Nov 27, 2017 · Terminated
  Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow CVC is indicated to provide short-ter
• Z-2698-2017 · Jun 12, 2017 · Terminated
  Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
• Z-2331-2017 · May 9, 2017 · Terminated
  1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for
• Z-1705-2017 · Mar 3, 2017 · Terminated
  The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
• 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