ARROW IPN033530Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902095756), received between Jul 11, 2018 and Jul 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

• MalfunctionJul 11, 2018Detachment of Device or Device Component; Difficult to Advance

  NOTES FROM OCCURRENCE REPORT: "PHYSICIAN ATTEMPTED TO INSERT A PICC LINE IN THE PATIENT'S RIGHT UPPER ARM. PHYSICIAN APPEARED TO BE HAVING DIFFICULTY ADVANCING PICC LINE AS THE PROCEDURE WAS TAKING LONGER THAN USUAL AND THE PATIENT WAS GRIMACING. PER RAD TECH THAT WAS ASSISTING PHYSICIAN WITH THE PROCEDURE, AS PHYSICIAN WAS PEELING AWAY THE PEEL AWAY SHEATH, A PORTION OF THE PEEL AWAY SHEATH BECAME DETACHED AND REMAINED INSIDE THE PATIENT'S RIGHT UPPER ARM. PATIENT RECEIVED CT OF RIGHT UPPER EXTREMITY, PICC LINE WAS INSERTED IN LEFT ARE (WITH EASE), AND RETAINED PICC LINE PIECE WAS RETRIEVED AND REMOVED BY PHYSICIAN". ADDITIONAL NOTE FROM OCCURRENCE REPORT: "SPOKE WITH PHYSICIAN AND HE IS CONFIDENT THIS WAS A MALFUNCTION OF THE PRODUCT. THIS IS BEING FOLLOWED UP PER PROTOCOL". ADDITIONAL NOTES FROM EMR: "A 21-GAUGE NEEDLE WAS PLACED IN THE TARGET VEIN AND THEN A PEEL-AWAY SHEATH WAS PLACED OVER A GUIDEWIRE. THE PICC LINE CATHETER WAS PLACED THROUGH THE SHEATH. HOWEVER, FOLLOWING REMOVAL OF THE SHEATH A PORTION OF THE DISTAL END BROKE OFF AND COULD NOT BE REMOVED FROM THE PATIENT. GIVEN THIS FINDING, AND INABILITY TO ADVANCE THE PICC WHICH WAS SUBSEQUENTLY REMOVED THE PATIENT WAS SE

  Patient problems: Foreign Body In Patient

  MAUDE report 7677029 ↗

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