ARROW IPN046311 (REF JC-05400-B)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801902029676), received between Mar 26, 2022 and Jan 26, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2023Material Twisted/Bent; Material Twisted/Bent

  REPORTED EVENT: THE CATHETER KINKED INSIDE THE SNAPLOCK WHICH CAUSED AN OCCLUSION; TREATMENT FLOW STOPPED. THE SNAPLOCK AND THE CATHETER WERE REPLACED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246255 ↗
• MalfunctionJan 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED EVENT: INCIDENT OCCURED ON (B)(6) 2022. THE PLUNGER OF THE LOR SYRINGE LEAKED.

  Patient problems: Insufficient Information

  MAUDE report 16233870 ↗
• MalfunctionJan 10, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE USE OF AN OBSTETRICAL EPIDURAL IT WAS OBSERVED THAT THE CATHETER WAS NOT PERFORATED. SO THE INJECTION WAS IMPOSSIBLE. IT WAS NECESSARY TO USE ANOTHER DEVICE AND THUS THE PATIENT HAD 2 CATHETERS INSERTED IN A ROW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131655 ↗
• MalfunctionDec 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON 30 OCTOBER 2022 IN THE MATERNITY DEPARTMENT, THE CATHETER HAD A HOLE ABOUT 5 CM FROM THE END ON THE PUNCTURE POINT SIDE AND LEAKED. THIS ISSUE WAS OBSERVED AFTER THE INSERTION OF THE DEVICE WHEN CHECKING THAT IT WAS WORKING PROPERLY. THE DEVICE WAS REMOVED. INCIDENT WITH NO CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959778 ↗
• MalfunctionNov 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED ISSUE: INCIDENT OCCURRED ON 16 OCTOBER 2022; THE PATIENT IS FEMALE 25-YEAR-OLD IN THE MATERNITY DEPARTMENT. THE EPIDURAL CATHETER WAS INSERTED AND DURING THE INFUSION OF THE TEST DOSE, WE OBSERVED A LEAK COMING FROM A HOLE IN THE BODY OF THE CATHETER. THE HOLE IS LOCATED 20-30 CM FROM THE END OF THE TUBING; THE CATHETER WAS REMOVED AND REPLACED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789250 ↗
• MalfunctionJun 27, 2022Material Separation; Material Separation

  DURING THE REMOVAL OF THE EPIDURAL CATHETER 3 HOURS BEFORE GIVING BIRTH, THE CATHETER SEPARATED DURING THE REMOVAL. IT LOOKS LIKE 7 CM REMAINED INSIDE THE FEMALE PATIENT. THERE WAS NO CONSEQUENCE FOR THE PATIENT. A SCAN HAS BEEN REQUESTED TO CHECK THE POSITION OF THE PART INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14829626 ↗
• MalfunctionJun 6, 2022Difficult to Advance; Difficult to Advance

  SEVERAL KITS FACED AN ISSUE. ANESTHETISTS HAVE GREAT DIFFICULTY ADVANCING THE CATHETER ONCE THE NEEDLE IS IN PLACE. SEVERAL CATHETERS COULD NOT BE INSERTED AND OTHERS NEEDED ADDITIONAL FORCE DURING INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606494 ↗
• MalfunctionMay 20, 2022Obstruction of Flow; Obstruction of Flow

  INCIDENT HAPPENED IN THE SURGERY. IT WAS IMPOSSIBLE TO INJECT INTO THE CATHETER (BLOCKAGE). WE HAD TO REMOVE THE CATHETER AND INSERT A NEW DEVICE IN THE FEMALE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455237 ↗
• InjuryMar 26, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  INVOLVED A FEMALE PATIENT WHO WAS IN MATERNITY ROOM. THE LOR SYRINGE DOES NOT IDENTIFY THE LOSS OF RESISTANCE DURING THE PROCEDURE OF INSERTION OF THE EPIDURAL CATHETER. WITH PHYSIOLOGICAL SALINE, THE SYRINGE STIFFENED AND RESISTANCE OCCURED LEADING TO A DURAL BREACH. ADDITIONAL INFORMATION: PATIENT WENT HOME. A BLOOD PATCH WAS APPLIED AND ANALGESICS PARACETAMOL PLUS IBUPROFENE. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: Spinal Column Injury

  MAUDE report 13915357 ↗

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