ARROW IPN923949Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902207453), received between Apr 25, 2022 and Aug 31, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2022Material Separation; Material Separation

  OUTSIDE OF CATHETER WAS UNCOILED FROM INNER PORTION SIMILAR TO UNWOUND STRING. DUE TO EPIDURAL CATHETER, PATIENT REQUIRED GENERAL ANESTHESIA. STABLE POST-DELIVERY. PATIENT EPIDURAL TUBING HAD A MECHANICAL TUBING MALFUNCTION. TUBING CATHETER WAS ASSESSED Q 1 HOURS. WHILE TRANSITIONING PATIENT FROM ROOM TO OR CONNECTION TUBING WAS BROKEN. STAFF, CHARGE, ANESTHESIOLOGIST, AND SAFETY OFFICER AWARE THAT CONNECTION TUBING BROKE. EPIDURAL CATHETER REMOVED IN THE OR AFTER STAT C-SECTION. TWO NURSES, SURGICAL TECH, AND ANESTHESIOLOGIST PRESENT FOR REMOVAL. CATHETER TUBING INTACT WITH NO COMPLICATIONS UPON REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328928 ↗
• InjuryApr 25, 2022Material Separation; Material Separation

  WHEN THE ANESTHETIST PROCEEDS TO REMOVE THE EPIDURAL CATHETER AFTER THE DELIVERY PROCESS, HE NOTICES THAT THE CATHETER COMES OUT INCOMPLETE. ONE PART REMAINED IN THE EPIDURAL SPACE BETWEEN L-3 AND L-4. THE ANESTHESIA MANAGER INFORMED US THAT THE PATIENT'S HUSBAND INDICATES THAT THE NEUROSURGEON WHO WILL INTERVENE WITH THE PATIENT TO REMOVE THE CATHETER ASKED TO SEE THE CATHETER, SO THEY DID NOT PROVIDE THE SAMPLE WHEN IT IS REMOVED, THIS WILL BE SENT TO PATHOLOGY FOR RECOGNITION. THE PATIENT HAD TO BE TRANSFERRED TO THE MEDICAL CENTER FOR THE INTERVENTION. THE CATHETER WAS REMOVED FROM THE PATIENT BY EXPLORATORY LAMNECTOMY. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 14192987 ↗

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-1174-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
• 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-1236-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
• 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