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ARROW IPN033348Recalls & reported problems

Teleflex Incorporated · PICC Peripherally Inserted Central Catheter Set with Blue FlexTip(R) Catheter Seldinger Access Set with 45 cm Wire · 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 00801902095312), received between Jun 21, 2023 and Jun 21, 2023 — classified as 1 malfunction.

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

4 other recalls cover devices cleared under the same FDA submission (K042126); 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

  • Material Deformation1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionJun 21, 2023Material Deformation; Material Deformation

    THE COMPLAINT IS REPORTED AS: "THE PATIENT WAS CATHETERIZED ON THE SECOND ATTEMPT, AND A GUIDE WIRE WAS PASSED. SUBSEQUENTLY, A DILATOR WAS INSERTED, BUT IT WAS NOT POSSIBLE TO ADVANCE IT DUE TO THE TIP OF THE DILATOR BREAKING OPEN. LATER, THE PATIENT EXPERIENCED RETRACTION, LEADING TO THE REMOVAL OF THE DILATOR." NO PATIENT INJURY WAS REPORTED. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE CRITICAL. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Insufficient Information

    MAUDE report 17174076 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042126. 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-2825-2015 · Aug 27, 2015 · Terminated
    Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
  • Z-2462-2015 · Jul 30, 2015 · Terminated
    PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
  • Z-1503-2009 · Feb 11, 2009 · Terminated
    Arrow Peripherally Inserted Central Catheter

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

How reports and recalls are matched · Editorial policy · Report an error on this page