ARROW IPN045611Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902005172), received between Jul 27, 2021 and Aug 29, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryAug 29, 2024Material Separation; Material Separation

  IT WAS REPORTED "PATIENT HAD AN UNEVENTFUL LABOR EPIDURAL PLACEMENT. AFTER DELIVERY OF THE CHILD, THE LABOR EPIDURAL CATHETER WAS DIFFICULT TO REMOVE. EVENTUALLY, THE CATHETER BROKE OFF AND LEFT ABOUT 2CM OF THE TIP OF THE CATHETER. THE PATIENT WAS INFORMED. A NEUROSURGEON WAS CONSULTED. CT SCAN SHOWED 1.8CM EPIDURAL TIP IN THE L3-4 EPIDURAL SPACE. 3 DAYS LATER THE PATIENT HAD A LAMINECTOMY TO REMOVE THE EPIDURAL CATHETER TIP AND ALL THE FRAGMENTS. OF NOTE, THE RETAINED EPIDURAL CATHETER TIP HAD A KNOT IN IT WHEN IT WAS REMOVED." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE AND DISCHARGED HOME".

  Patient problems: Foreign Body In Patient

  MAUDE report 20100463 ↗
• MalfunctionJul 27, 2021Obstruction of Flow; Obstruction of Flow

  WE ARE WRITING THIS EMAIL TO INFORM YOU OF A MANUFACTURING DEFECT THAT WE ENCOUNTERED IN ONE OF THE TELEFLEX ARROW FLEXTIP PLUS COMBINED SPINAL - EPIDURAL KITS. THE LUMEN OF THE EPIDURAL LUMEN WAS BLOCKED BY A PIECE OF PLASTIC. WE REVIEWED THE LITERATURE AND RECOGNIZED THAT THIS COMPLICATION HAS NEVER BEEN SEEN BEFORE. WE ARE WRITING IT AS A CASE REPORT TO BE PUBLISHED IN THE INTERNATIONAL JOURNAL OF OBSTETRIC ANESTHESIA. WE HAVE ATTACHED IMAGES OF THE BLOCKED EPIDURAL LUMEN WITH THIS EMAIL FOR YOU TO SEE. THE DEVICE WAS BEING USED ON A PATIENT. THE PATIENT WAS STABLE AND WAS PRESENTING IN LABOR FOR SPONTANEOUS VAGINAL DELIVERY. THE MEDICAL INTERVENTION REQUIRED WAS WE NEEDED TO REDO THE EPIDURAL WITH A DIFFERENT KIT FROM A DIFFERENT LOT NUMBER AS WE COULD NOT THREAD THE CATHETER THROUGH THIS NEEDLE. THE KIT WAS DISCARDED AFTER WE TOOK PICTURES OF THE LUMEN (FOR PUBLISHING PURPOSES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232383 ↗