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ARROW IPN033311Recalls & reported problems

Teleflex Incorporated · Peripherally Inserted Central Catheter Kit with Blue FlexTip(R) Catheter and Placement 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 00801902012746), received between Dec 10, 2015 and Dec 10, 2015 — classified as 1 malfunction.

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

  • Detachment of Device or Device Component1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionDec 10, 2015Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING INSERTION IN THE RADIOLOGY DEPT., THE TABS ON THE PEEL AWAY SHEATH TORE OFF CLEANLY ON ONE SIDE MAKING REMOVAL OF THE SHEATH FROM THE CATHETER DIFFICULT. THE USER WAS ABLE TO REMOVE THE SHEATH AND MAINTAIN ACCESS WITH THE CATHETER. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO ADDITIONAL HARM TO THE PATIENT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9638489 ↗

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