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ARROW IPN037867Recalls & reported problems

Teleflex Incorporated · ARROW ENDURANCE(TM) Extended Dwell Peripheral Catheter System · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902133066), received between Sep 15, 2021 and Nov 20, 2022 — classified as 1 injury, 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K163513); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. May 19, 2023Open, Classified

    Potential for catheter separation or leakage

    Z-1826-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Material Deformation1
  • Material Separation1

Patient problems

  • Foreign Body In Patient1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 20, 2022Material Separation; Material Separation

    IT WAS REPORTED AN ENDURANCE CATHETER WAS RETAINED IN THE PATIENT'S ARM. THE IV WAS LEAKING AND THE CATHETER WAS FOUND NOT ATTACHED TO THE HUB OF THE DEVICE. AN X-RAY WAS DONE AND THE PATIENT HAD THE CATHETER LODGED IN HIS ARM. THE PATIENT WENT TO THE OR AND THE CATHETER WAS SUCCESSFULLY REMOVED. THERE WERE NO COMPLICATIONS WITH THE PROCEDURE. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE FINE.

    Patient problems: Foreign Body In Patient

    MAUDE report 15831629 ↗
  • MalfunctionSep 15, 2021Material Deformation; Material Deformation

    WHEN THE USER TOOK THE NEEDLE OUT OF AN ENDURANCE CATHETER, THE GUIDEWIRE WAS NOT PRESENT. AFTER BREAKING OPEN THE CATHETER TO ENSURE THE WIRE WAS NOT IN THE PATIENT, THE GUIDEWIRE WAS FOUND STILL IN THE CATHETER. THE USER WAS UNABLE TO SLIDE IT UP AND DOWN WITH THE SLIDER. THE GUIDEWIRE WAS INTACT. NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12473808 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163513. One submission often covers many models, so check the product and lot details in each record.

  • Z-0837-2020 · Dec 6, 2019 · Terminated
    Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH

Other Catheter,intravascular,therapeutic,short-term less than 30 days devices

All Catheter,intravascular,therapeutic,short-term less than 30 days devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.