ARROW IPN040163Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30801902126420), received between Aug 12, 2022 and Oct 1, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "POSTPARTUM PATIENT WHO RECEIVED EVALUATION FROM AN ANESTHESIOLOGIST , WHO PERFORMED THE EPIDURAL CATHETER REMOVAL ON WHICH PRESENTS RUPTURE, LEAVING A FRAGMENT OF THE CATHETER IN THE LEFT FORAMINAL LOCATION IN L3/L4 IN CONTACT WITH THE L3 EMERGING ROOT, ACCORDING TO A LUMBAR SPINE CT SCAN REPORT." AWAITING ADDITIONAL INFORMATION FROM THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20342759 ↗
• InjuryMar 29, 2024Corroded; Patient-Device Incompatibility; Corroded; Patient-Device Incompatibility

  IT WAS REPORTED "THE CLINICIAN OBSERVED A PURULENT DISCHARGE AT THE PUNCTURE SITE. HE THEN REMOVED THE COMPRESSES AND NOTICED THAT THE FILTER WAS CORRODED, ORANGE-STAINED AND POROUS." ADDITIONAL INFORMATION REPORTS THERE WAS NO SYSTEMIC INFECTION AND THE PATIENT WAS NOT SEPTIC PRIOR TO INSERTING THE CATHETER. THE FILTER WAS CHANGED AND ANTIBIOTICS WAS ADMINISTERED. THE PATIENTS CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: Purulent Discharge

  MAUDE report 19004580 ↗
• MalfunctionOct 28, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2022 IN THE OBSTETRIC BLOCK DURING CHILDBIRTH, THE WINGCLIP SNAPLOCK SEPARATED FROM THE FILTER. THE CONSEQUENCE WAS A LEAK OF THE TREATMENT AND THE NON-ADMINISTRATION OF THE PATIENT'S EPIDURAL ANALGESIA. THIS INTERRUPTION LASTED 1 HOUR WHILST CLEANING AND REPLACING THE CATHETER. IT CAUSE A RISK FOR THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15692043 ↗
• MalfunctionSep 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: INCIDENT OCCURRED ON (B)(6) 2022 WHILST GIVING BIRTH PROCEDURE. THE CONNECTION OF THE CATHETER WAS CHECKED PRIOR TO INSERT IN THE PATIENT. ALL WAS FINE. DURING INSERTION IN THE PATIENT A LIQUID LEAK WAS OBSERVED. THERE WAS NO CONSEQUENCE FOR THE PATIENT BUT ANOTHER INSERTION OF CATHETER WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477269 ↗
• MalfunctionSep 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  WE FACED ISSUES WITH THE PLUNGER OF THE SYRINGES OF THE KIT, THERE WERE SALINE LEAKS.

  Patient problems: Insufficient Information

  MAUDE report 15362956 ↗
• MalfunctionAug 12, 2022Obstruction of Flow; Obstruction of Flow

  THIS COMPLAINT COVERS EVENTS WITH UNKNOWN DETAILS. IT WAS REPORTED THAT IN ON (B)(6) 2022 A DOCTOR OBSERVED A DIFFICULTY DURING THE INJECTION OF PERIDURAL. SIMILAR EVENTS OF THIS ISSUE OF DIFFICULTIES TO INJECT THE PRODUCT HAVE BEEN REPORTED IN THE DEPARTMENT BUT WITHOUT BEING REPORTED WITH ANY AVAILABLE DETAILS. IT IS UNKNOWN WHAT PART OF THE KIT IS THE CAUSE OF THE INCIDENT. WE CANNOT PROVIDE THIS INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 15218770 ↗
• MalfunctionAug 12, 2022Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2022 BEFORE GIVING BIRTH, THE DOCTOR OBSERVED A DIFFICULTY DURING THE INJECTION OF PERIDURAL. INDEED, THE PERIDURAL ANESTHETIC KIT DOES NOT INJECT THE PRODUCT OR WE HAVE TO APPLY FORCE ON THE PLUNGER. CLINICAL CONSEQUENCES: BECAUSE OF THIS, THE DOCTOR DECIDED TO CHANGE THE ENTIRETY OF THE KIT AND TO PUNCTURE THE PATIENT AGAIN. THERE WERE NO OTHER MEDICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218693 ↗

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-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-1177-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
• Z-1237-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
• Z-1236-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
• Z-1238-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN