ARROW IPN046779Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 40801902014403), received between Oct 27, 2021 and Feb 3, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

9 other recalls cover devices cleared under the same FDA submission (K140110); 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED THAT "DURING ATTEMPTED REMOVAL OF AN EPIDURAL CATHETER, THE PRIMARY RN ENCOUNTERED RESISTANCE ON THE INITIAL PULL. THE PATIENT WAS REPOSITIONED AND A SECOND REMOVAL ATTEMPT WAS MADE, AGAIN MEETING RESISTANCE. A SECOND RN ASSISTED, AND ADDITIONAL ATTEMPTS WERE MADE WITH PATIENT REPOSITIONING, BUT RESISTANCE PERSISTED. ANESTHESIA WAS CONSULTED TO ASSIST WITH CATHETER REMOVAL. UPON EVALUATION, ANESTHESIA ALSO ENCOUNTERED RESISTANCE DESPITE REPOSITIONING. ADDITIONAL TRACTION WAS APPLIED DURING REMOVAL, AT WHICH TIME THE CATHETER FRACTURED, RESULTING IN RETENTION OF A PORTION OF THE CATHETER. SUBSEQUENT IMAGING DEMONSTRATED A RETAINED EPIDURAL CATHETER FRAGMENT NEAR THE SUPERIOR MARGIN OF THE L3 SPINOUS PROCESS, SLIGHTLY LEFT OF MIDLINE, ENTIRELY WITHIN THE PARASPINAL SOFT TISSUE. AFTER CONSULTATION WITH NEUROSURGERY, THE DECISION WAS MADE TO MANAGE THE PATIENT CONSERVATIVELY WITH OBSERVATION AND FOLLOW-UP IN TWO MONTHS. THE PATIENT WAS DISCHARGED HOME WITHOUT SURGICAL REMOVAL OF THE RETAINED CATHETER FRAGMENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250872 ↗
• MalfunctionApr 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "A TOTAL OF 3 SEPARATE INCIDENTS HAVE OCCURRED WITH THE REMOVAL OF THE EPIDURAL CATHETER. ON (B)(6), THE CATHETER HAD AN APPARENT KNOT WITHIN THE PATIENT WHICH PREVENTED IT FROM BEING REMOVED. IT THEN HAD TO BE SURGICALLY REMOVED. THE OTHER INCIDENTS WERE DESCRIBED AS THE CATHETER "SNAPPING" UPON REMOVAL OF THE PATIENT." ASSOCIATED COMPLAINTS 9680794-2025-00344, 9680794-2025-00337.

  Patient problems: Insufficient Information

  MAUDE report 21917087 ↗
• MalfunctionApr 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "A TOTAL OF 3 SEPARATE INCIDENTS HAVE OCCURRED WITH THE REMOVAL OF THE EPIDURAL CATHETER. ON (B)(6), THE CATHETER HAD AN APPARENT KNOT WITHIN THE PATIENT WHICH PREVENTED IT FROM BEING REMOVED. IT THEN HAD TO BE SURGICALLY REMOVED. THE OTHER INCIDENTS WERE DESCRIBED AS THE CATHETER "SNAPPING" UPON REMOVAL OF THE PATIENT. (THIS COMPLAINT)" ASSOCIATED COMPLAINTS 9680794-2025-00344 AND 9680794-2025-00336.

  Patient problems: Insufficient Information

  MAUDE report 21880308 ↗
• InjuryApr 22, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "A TOTAL OF 3 SEPARATE INCIDENTS HAVE OCCURRED WITH THE REMOVAL OF THE EPIDURAL CATHETER. ON (B)(6), THE CATHETER HAD AN APPARENT KNOT WITHIN THE PATIENT WHICH PREVENTED IT FROM BEING REMOVED. IT THEN HAD TO BE SURGICALLY REMOVED. THE OTHER INCIDENTS WERE DESCRIBED AS THE CATHETER "SNAPPING" UPON REMOVAL OF THE PATIENT." ASSOCIATED COMPLAINTS 9680794-2025-00344, 9680794-2025-00337 AND 9680794-2025-00336.

  Patient problems: Foreign Body In Patient

  MAUDE report 21880261 ↗
• MalfunctionDec 7, 2021No Flow; No Flow

  DOCTOR INSERTED AND PLACED FLEX TIP PLUS EPIDURAL SUCCESSFULLY INTO PATIENT BUT WAS UNABLE TO PUSH MEDICATION THROUGH THE CATHETER. CATHETER WAS REMOVED AND A SPINAL BLOCK WAS PERFORMED FOR A C-SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953771 ↗
• MalfunctionOct 27, 2021Break; Break

  PER THE DOCTOR CATHETER TIP BROKE OFF WHEN REMOVING FROM PATIENT AND TIP IS STILL IN PATIENTS EPIDURAL SPACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12703798 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140110. One submission often covers many models, so check the product and lot details in each record.

• Z-2371-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION K
• Z-1913-2026 · Mar 11, 2026 · Open, Classified
  FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arr
• Z-2288-2020 · May 8, 2020 · Open, Classified
  Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05
• Z-1177-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
• Z-1172-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
• Z-1174-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
• Z-1237-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
• Z-1238-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
• Z-1236-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1