ARROW IPN038190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902137422), received between Mar 18, 2022 and Mar 18, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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. 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.

• MalfunctionMar 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THE SHEATH WAS BEING USED, SHEATH BUCKLED AND A NEW ONE HAD TO BE USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804491 ↗
• MalfunctionMar 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THE SHEATH WAS BEING USED BY THE CLINICIAN AND A DEFECT WAS NOTICED ALONG THE BODY OF THE SHEATH WHEN INSERTING. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804458 ↗

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