ARROW IPN046313 (REF JC-05400-DCS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 40801902062510), received between Sep 27, 2021 and Jun 24, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

4 other recalls cover devices cleared under the same FDA submission (K103658); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT: "ON (B)(6), I PLACED AN EPIDURAL CATHETER FOR LABOR ANALGESIA (BRAND: ARROW, FLEX TIP PLUS EPIDURAL CATHETERIZATION SET). AS ALWAYS, I CHECKED THE INTEGRITY OF THE DEVICE BEFORE PLACEMENT AND PERFORMED AN ASPIRATION TEST, WHICH WAS NEGATIVE, AND A TEST DOSE, WHICH ALSO YIELDED NEGATIVE RESULTS. I THEN SECURED THE EPIDURAL CATHETER WITH THREE PACKS OF STERI-STRIPS (A TOTAL OF 9 STRIPS), APPLIED TWO TRANSPARENT POLYURETHANE DRESSINGS ON TOP, AND CREATED A FRAME USING MEDI FIX TAPE (POLYURETHANE ADHESIVE TAPE) TO ENSURE THE CATHETER COULD NOT BECOME DISPLACED IN ANY WAY. I COMPLETED THE DRESSING TO ENSURE THE CATHETER WAS NOT EXPOSED. THE CATHETER FUNCTIONED CORRECTLY THROUGHOUT THE ENTIRE DURATION OF LABOR. I ADMINISTERED THE FIRST ANALGESIC BOLUS AND THEN CONNECTED A PUMP THAT RELEASED ANALGESIC MEDICATION EVERY HOUR. I WAS LATER CALLED TO REMOVE THE DEVICE, AS IT WAS NO LONGER NECESSARY. AT THE TIME OF REMOVAL, THE CATHETER APPEARED TO BE BROKEN IN TWO PLACES, WITH THE METAL CORE EXPOSED OVER SEVERAL CENTIMETERS. THE DRESSING WAS NEITHER TAMPERED WITH NOR WET, INDICATING THAT THE CATHETER HAD BEEN FUNCTIONING PROPERLY UP UNTIL DELIVERY (THIS WAS ALL CONFIRMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313631 ↗
• MalfunctionMar 26, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT "AFTER THE INSERTION OF THE DEVICE FOR LABOR ANALGESIA AND THE ADMINISTRATION OF 15 ML OF LOCAL ANESTHETIC, THE FILTER BECAME COMPLETELY FILLED WITH BLOOD DESPITE ALL THE ASPIRATION CHECKS AND TESTS WITH THE LOCAL ANESTHETIC. THE CATHETER IS UNDOUBTEDLY MORE RIGID THAN THE ONE USED PREVIOUSLY AND SLIDES WITH DIFFICULTY INSIDE THE NEEDLE, IT CREATES FRICTION, AND THIS IS FELT ABOVE ALL DURING THE NEEDLE REMOVAL PROCEDURE. THE DOCTOR SAYS THAT DUE TO ITS RIGIDITY THE CATHETER SLIPS OUT WHEN THE INTRODUCER IS REMOVED. TO PREVENT THIS, THEY PUSH THE CATHETER FURTHER IN, RISKING THE POSSIBILITY OF PUNCTURING A BLOOD VESSEL, WHICH IS PARTICULARLY ENGORGED IN PREGNANT PATIENTS. A VESSEL HAS BEEN DAMAGED.".

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 21695726 ↗
• InjuryJul 17, 2024Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED "DURING REMOVAL, THE PLASTIC COMPONENT OF THE CATHETER HAD A NEAT SPLIT, WITH THE FRAME UNCOILING WHEN ATTEMPTING TO REMOVE. THE DOCTOR RECOMMENDED THAT THE CATHETER BE MAINTAINED IF REMOVAL WAS IMPOSSIBLE. A LUMBAR X-RAY WAS PERFORMED AND THE CATHETER WAS FOUND TO BE RADIOPAQUE. A NEW ATTEMPT TO REMOVE THE PART RESULTED IN THE CATHETER BEING COMPLETELY REMOVED. THE REST OF THE SURGERY WAS MAINTAINED TO HAPPEN." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Foreign Body In Patient

  MAUDE report 19760407 ↗
• MalfunctionNov 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PLACEMENT OF THE EPIDURAL CATHETER IN THE PHASE OF LABOR DELIVERY, THE SYRINGE SHOWED A LEAK FROM THE PLUNGER, BOTH OF LIQUID AND RESISTANCE, WITH POTENTIAL RISK OF DURAL PUNCTURE. WE REPLACE THE DEVICE AS SOON AS THE PROBLEM WAS NOTICED AND BEFORE IT WAS USED ON THE PATIENT. TWO KITS WITH THE SAME ISSUES WERE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730098 ↗
• MalfunctionNov 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PLACEMENT OF THE EPIDURAL CATHETER IN THE PHASE OF LABOR DELIVERY, THE SYRINGE SHOWED A LEAK FROM THE PLUNGER, BOTH OF LIQUID AND RESISTANCE, WITH POTENTIAL RISK OF DURAL PUNCTURE. WE REPLACE THE DEVICE AS SOON AS THE PROBLEM WAS NOTICED AND BEFORE IT WAS USED ON THE PATIENT. TWO KITS WITH THE SAME ISSUES WERE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15728192 ↗
• MalfunctionOct 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A CATHETER WAS INSERTED WITH SUCCESS IN THE PATIENT. THE SUCTION TEST INDICATED AN AIR REFLUX. WHEN THE SALINE WAS INJECTED WE DISCOVERED THAT THERE WAS A LEAK ALONG THE LENGTH OF THE CATHETER. WE REMOVED THE CATHETER AND REPLACED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568585 ↗
• MalfunctionSep 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HAPPENED IN THE MATERNITY DEPARTMENT. ON THE SAME NIGHT, FROM (B)(6) 2021, THERE WERE THE OCCURRENCE OF A SIMILAR INCIDENT WITH 5 DIFFERENT FEMALE PATIENTS. THE DOCTOR INVOLVED IS ACCUSTOMED TO USING THESE EPIDURAL CATHETERS. THE CATHETERS HAD BEEN CHECKED AND TESTED BEFORE INSERTION. THE INSERTION WAS PERFORMED WITH SUCCESS. WHEN THE TREATMENT WAS INFUSED THERE WERE LEAKS OF THE LIQUID INFUSED AFTER 1 HOUR TO 1 HOUR 30 MINUTES AFTER STARTING. CONSEQUENCE: 2 DIFFERENT OPTIONS WERE TAKEN/OBSERVED ACCORDING TO THE PATIENTS: THE CATHETER WAS REMOVED, AND ANOTHER CATHETER WAS INSERTED; THE TREATMENT WAS INEFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533399 ↗
• MalfunctionSep 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HAPPENED IN THE MATERNITY DEPARTMENT. ON THE SAME NIGHT, FROM THE (B)(6) 2021, THERE WERE THE OCCURRENCE OF A SIMILAR INCIDENT WITH 5 DIFFERENT FEMALE PATIENTS. THE DOCTOR INVOLVED IS ACCUSTOMED TO USING THESE EPIDURAL CATHETERS. THE CATHETERS HAD BEEN CHECKED AND TESTED BEFORE INSERTION. THE INSERTION WAS PERFORMED WITH SUCCESS. WHEN THE TREATMENT WAS INFUSED THERE WERE LEAKS OF THE LIQUID INFUSED AFTER 1 HOUR TO 1 HOUR 30 MINUTES AFTER STARTING. CONSEQUENCE: 2 DIFFERENT OPTIONS WERE TAKEN/OBSERVED ACCORDING TO THE PATIENTS: THE CATHETER WAS REMOVED, AND ANOTHER CATHETER WAS INSERTED; THE TREATMENT WAS INEFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533374 ↗
• MalfunctionSep 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HAPPENED IN THE MATERNITY DEPARTMENT. ON THE SAME NIGHT, FROM THE (B)(6) 2021, THERE WERE THE OCCURRENCE OF A SIMILAR INCIDENT WITH 5 DIFFERENT FEMALE PATIENTS. THE DOCTOR INVOLVED IS ACCUSTOMED TO USING THESE EPIDURAL CATHETERS. THE CATHETERS HAD BEEN CHECKED AND TESTED BEFORE INSERTION. THE INSERTION WAS PERFORMED WITH SUCCESS. WHEN THE TREATMENT WAS INFUSED THERE WERE LEAKS OF THE LIQUID INFUSED AFTER 1 HOUR TO 1 HOUR 30 MINUTES AFTER STARTING. CONSEQUENCE: 2 DIFFERENT OPTIONS WERE TAKEN/OBSERVED ACCORDING TO THE PATIENTS: THE CATHETER WAS REMOVED, AND ANOTHER CATHETER WAS INSERTED; THE TREATMENT WAS INEFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533355 ↗
• MalfunctionSep 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HAPPENED IN THE MATERNITY DEPARTMENT. ON THE SAME NIGHT, FROM THE (B)(6) TO (B)(6) 2021, THERE WERE THE OCCURRENCE OF A SIMILAR INCIDENT WITH 5 DIFFERENT FEMALE PATIENTS. THE DOCTOR INVOLVED IS ACCUSTOMED TO USING THESE EPIDURAL CATHETERS. THE CATHETERS HAD BEEN CHECKED AND TESTED BEFORE INSERTION. THE INSERTION WAS PERFORMED WITH SUCCESS. WHEN THE TREATMENT WAS INFUSED THERE WERE LEAKS OF THE LIQUID INFUSED AFTER 1 HOUR TO 1 HOUR 30 MINUTES AFTER STARTING. CONSEQUENCE: 2 DIFFERENT OPTIONS WERE TAKEN/OBSERVED ACCORDING TO THE PATIENTS: THE CATHETER WAS REMOVED, AND ANOTHER CATHETER WAS INSERTED; THE TREATMENT WAS INEFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533330 ↗
• MalfunctionSep 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HAPPENED IN THE MATERNITY DEPARTMENT. ON THE SAME NIGHT, FROM THE (B)(6) TO (B)(6) 2021, THERE WERE THE OCCURRENCE OF A SIMILAR INCIDENT WITH 5 DIFFERENT FEMALE PATIENTS. THE DOCTOR INVOLVED IS ACCUSTOMED TO USING THESE EPIDURAL CATHETERS. THE CATHETERS HAD BEEN CHECKED AND TESTED BEFORE INSERTION. THE INSERTION WAS PERFORMED WITH SUCCESS. WHEN THE TREATMENT WAS INFUSED THERE WERE LEAKS OF THE LIQUID INFUSED AFTER 1 HOUR TO 1 HOUR 30 MINUTES AFTER STARTING. CONSEQUENCE: 2 DIFFERENT OPTIONS WERE TAKEN/OBSERVED ACCORDING TO THE PATIENTS: THE CATHETER WAS REMOVED, AND ANOTHER CATHETER WAS INSERTED; THE TREATMENT WAS INEFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533316 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103658. One submission often covers many models, so check the product and lot details in each record.

• Z-2364-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;
• Z-1179-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
• Z-1962-2018 · Apr 11, 2018 · Terminated
  SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
• Z-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound