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ARROW IPN046834Recalls & reported problems

Teleflex Incorporated · FlexTip Plus(R) Epidural Catheterization Kit · Class 2

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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902128370), received between Dec 7, 2021 and Dec 7, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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 Split, Cut or Torn1

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.

  • InjuryDec 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

    DURING THE REMOVAL OF THE DEVICE THE EPIDURAL CATHETER WAS FOUND CUT/SEPARATED. A PART OF THE DEVICE REMAINED IN THE SOFT PARTS OF THE PATIENT. IT REQUIRED AN INTERVENTION IN THE SURGERY ROOM TO REMOVE THE PART. THE USER WAS EXPERIENCED WITH THIS DEVICE. DURING THE REMOVAL THE DEVICE APPEARS TO HAVE A RETURN UNDER THE SKIN REQUIRING THE CATHETER TO BE PULLED OUT OF THE INTERVERTEBRAL SPACE. THERE WAS THUS A SPREAD OF THE DEVICE FOLLOWED BY A CLEAR BREAK. THE USER DID NOT USE A SCALPEL. THE CONSEQUENCE WAS THAT THE PATIENT REMAINED LONGER IN THE HOSPITAL BECAUSE OF THE INTERVENTION IN THE SURGERY ROOM TO REMOVE THE BROKEN PART.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12955722 ↗

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Sources and updates

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