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ARROW IPN033536Recalls & reported problems

Teleflex Incorporated · ArrowEVOLUTION(TM) PICC Set featuring Chlorag+ard(TM) Antimicrobial/Antithrombogenic Technology with Pressure Injectable Catheter with Blue FlexTip(R) · Class 2 · Implant

All models of ARROW (1494)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20801902095767), received between Aug 23, 2023 and Aug 23, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (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

Device problems

  • Separation Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 23, 2023Separation Failure; Separation Failure

    IT WAS REPORTED WHEN THE RN BEGAN TO PEEL AWAY THE SHEATH, PART OF THE SHEATH BROKE OFF FROM THE BOTTOM PORTION OF THE SHEATH. THE SHEATH WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT AND NOTHING WAS LEFT BEHIND. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17607144 ↗

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-1819-2019 · Apr 23, 2019 · Terminated
    Arrow PICC with Chlorag+ard Technology Product Code: PR 45541 HPHNL
  • 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-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

Other Catheter, intravascular, therapeutic, long-term greater than 30 days devices

All Catheter, intravascular, therapeutic, long-term greater than 30 days devices →

Sources and updates

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