ARROW IPN923013Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10801902205435), received between Sep 18, 2023 and Nov 19, 2025 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K963257); 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.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2394-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "WIRE FELL APART". NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 23597337 ↗
• MalfunctionJul 9, 2025Break; Obstruction of Flow; Break; Obstruction of Flow

  IT WAS REPORTED "SPECIFICALLY THE SHEATH WAS OBSTRUCTING AND BROKE APART INCORRECTLY." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458157 ↗
• MalfunctionJan 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "CUSTOMER STATES PEEL-AWAY SHEATH OVER DILATOR IS CRACKED AT BASE OF PEEL-AWAY PORTION. THERE IS A VISIBLE SPLIT DOWN THE DARK BLUE LINE ON THE SHEATH. THERE IS NOTICEABLE SEPARATION IN THE TRANSITION FROM SHEATH TO DILATOR. CUSTOMER FOUND DIFFICULTY INSERTING AND STOPPED PROCEDURE UPON NOTICING THE DAMAGE. SHE THEN USED A SINGLE STERILE SHEATH TO COMPLETE THE PROCEDURE. SHE REPORTED SHE HAS SEEN A TOTAL OF 4 DAMAGED SHEATHS FROM THIS LOT NUMBER". THE PATIENT HAD NO HARM OR INJURY. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00073, 9680794-2025-00072, 9680794-2025-00071, 9680794-2025-00070 AND 9680794-2025-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240821 ↗
• MalfunctionJan 16, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED "DURING INSERTION PROCEDURE, 4.5FR AGBA SINGLE LUMEN MIDLINE WOULD NOT PASS THROUGH THE SHEATH INTRODUCER IN THE KIT. THEY DROPPED ANOTHER SEPARATE SHEATH INTRODUCER AND STILL COULD NOT PASS MIDLINE". THE CONDITION OF THE REPORTED TO BE 'FINE' AND THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21166961 ↗
• MalfunctionNov 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED "WHEN IT CAME TIME TO BREAK-AWAY/REMOVE THE GLIDE-THRU PEEL-AWAY SHEATH, A PORTION OF THE WHITE SHEATH BODY BROKE AWAY FROM THE BREAK-AWAY TAB/HANDLE PREMATURELY, NOT ALLOWING THE SHEATH REMOVAL PROCESS TO BE COMPLETED. THE MIDLINE & SHEATH WERE FULLY REMOVED AS A UNIT, A NEW KIT WAS OPENED, & THE PROCEDURE WAS COMPLETED SUCCESSFULLY." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797366 ↗
• MalfunctionOct 24, 2024Fitting Problem; Difficult to Advance; Fitting Problem; Difficult to Advance

  IT WAS REPORTED "WHEN IT CAME TIME TO THREAD THE MIDLINE CATHETER THRU THE GLIDE-THRU PEEL-AWAY SHEATH, THE MIDLINE CATHETER SEEMED TOO BIG AND WOULD NOT FIT. CATHETER & SHEATH WAS REMOVED, A NEW KIT WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20526129 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "INSERTION 9/25/24 13:05 RT BRACHIAL VEIN. STERILE CHG DRESSING RAPID RESPONSE TEAM CALLED IMMEDIATELY, PATIENT ADMITTED TO ICU." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL". ADDITIONAL INFORMATION REPORTS "INITIAL CALL WAS FOR FOR SEIZURES. ON ARRIVAL THE PATIENT WAS UNRESPONSIVE, BREATHING AGONALLY, WITH A PULSE. AT THAT TIME WE CALLED A MAYDAY TO HAVE SOMEONE ASSIST WITH INTUBATION AND TO HAVE A PHYSICIAN TO THE BEDSIDE. WE STARTED RESCUE BREATHING WITH A TRUMPET AND THEN AN ORAL AIRWAY UNTIL SHE WAS SUCCESSFULLY INTUBATED. DURING THAT TIME WE STARTED A BOLUS OF NS, A LEVOPHED DRIP FOR BP SUPPORT FOR A BLOOD PRESSURE, AND THEN A PROPOFOL DRIP STARTED AFTER SHE WAS INTUBATED. AT THAT TIME WE TRANSFERRED TO THE ICU WHERE THE CRITICAL CARE TEAM WAS PREPARED AND READY."

  Patient problems: Insufficient Information

  MAUDE report 20522673 ↗
• MalfunctionMay 28, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED "SHEATH INTRODUCER WING BROKE OFF DURING USE". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404057 ↗
• MalfunctionMay 28, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPROTED "SHEATH INTRODUCER WING SNAPPED OFF DURING USE". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404024 ↗
• MalfunctionMay 15, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: "GUIDEWIRE WAS SHEARED DURING INSERTION. NO HARM WAS CAUSED TO THE PATIENT. THE PATIENT WAS X-RAYED, AND NONE OF THE WIRE WAS IN THE PATIENT". NO PATIENT INJURY OR CONSEQUENCE. NO MEDICAL INTERVENTION REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321251 ↗
• MalfunctionMay 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: PATIENT HAD A MIDLINE PLACED BY IV TEAM. AS IV TEAM RN FINISHED MIDLINE PLACEMENT, ONE OF THE WHITE PEEL AWAY TABS ON THE SHEATH BROKE AWAY. NO HARM TO PATIENT. IV TEAM RN ABLE TO REMOVE SHEATH WITHOUT DAMAGING OR MOVEMENT OF MIDLINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219286 ↗
• MalfunctionApr 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: NURSE WAS PLACING THE LINE AND WHEN SHE WENT TO PULL IT BACK TO PEEL THE INTRODUCER, THE WHITE WING SNAPPED OFF ON ONE SIDE. THE LINE WAS ALREADY PLACED. SHE WAS PEELING IT TO REMOVE IT. THE ENTIRE DEVICE WAS REMOVED AND THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215181 ↗
• MalfunctionApr 30, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED "BROKEN SHEATH". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION WAS REQUESTED, NO FURTHER DETAILS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19215051 ↗
• MalfunctionApr 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "MIDLINE PEEL-AWAY SHEATH ACCORDION UP DURING INSERTION. IT PUSHED BACK ON ITSELF. A SECOND KIT WAS NEEDED TO COMPLETE THE PROCEDURE." THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103118 ↗
• MalfunctionMar 22, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING INSERTION OF THE SHEATH, THE SHEATH BUCKLED AND COILED ON ITSELF AND WAS BENT. IT DID NOT COME APART. A NEW SHEATH HAD TO BE USED." NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18962540 ↗
• MalfunctionFeb 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: THE PEAL AWAY SHEATH PEELED BACK ON ITSELF AT THE TRANSITION POINT OF THE SHEATH AND DILATOR. ANOTHER DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730726 ↗
• MalfunctionDec 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: ONE ARM OF THE PEEL-AWAY SHEATH BROKE OFF THE SHEATH. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18254833 ↗
• MalfunctionDec 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: ARM OF THE PEEL-AWAY SHEATH BROKE OFF. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18254739 ↗
• MalfunctionOct 31, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT: DILATOR/SHEATH PUT OVER THE GUIDEWIRE TO INTRODUCE INTO THE PATIENT. THE SHEATH BUCKLED. ADDITIONAL INFORMATION: THE INSERTION SITE WAS THE RIGHT BASILIC. SKIN WAS REPORTED AS TOUGH. THE DILATOR WAS REMOVED IN ITS ENTIRETY AFTER IT BUCKLED. ANOTHER SHEATH WAS USED TO FINISH THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18037660 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED THE SHEATH INTRODUCER BROKE APART INCORRECTLY. THE DEVICE WAS COMPLETELY REMOVED AND A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18006077 ↗
• MalfunctionOct 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: THE PLASTIC ON SHEATH BROKE APART INCORRECTLY CAUSING LINE TO COME OUT AND PROCEDURE TO BE REPEATED. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17938178 ↗
• MalfunctionOct 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: THE WHITE TAB ON SHEATH INTRODUCER BROKE APART. IT IS REPORTED THAT IT WAS USED AS PER IFU. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903239 ↗
• MalfunctionOct 2, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE SHEATH KINKED AND ROLLED BACK AT THE TRANSITION DURING THE PROCEDURE AND A REPLACEMENT KIT WAS NEEDED TO COMPLETE THE PROCEDURE. THE USER REPORTED "THE DILATOR TIP ENTERED THE SKIN BUT THE SHEATH WOULD NOT ENTER THE SKIN DESPITE HOLDING IT CLOSE TO THE ARM AND USING ROTATION WHILE ADVANCING. AS I APPLIED INCREASED PRESSURE, THE SHEATH PUSHED UP/BUCKLED/KINKED." THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17855822 ↗
• MalfunctionSep 29, 2023Material Deformation; Material Deformation

  IT WAS REPORTED "THE SHEATH KINKED AND ROLLED BACK AT THE TRANSITION DURING THE PROCEDURE AND A REPLACEMENT KIT WAS NEEDED TO COMPLETE THE PROCEDURE". NO PATIENT HARM REPORTED. THE SHEATH WAS REMOVED IN ITS ENTIRETY. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843836 ↗
• MalfunctionSep 18, 2023Break; Break

  CUSTOMER REPORTED "WHITE PULL TAB ON BREAK-AWAY INTRODUCER CAME OFF WHILE I WAS PULLING IT APART". THE USER REPORTED THE LEFT SIDE CAME OFF AND THE USER "GRABBED THE REMAINING SHEATH AND PEELED IT AWAY". THE SHEATH WAS REMOVED IN ITS ENTIRETY AND THE CATHETER WAS SUCCESSFULLY PLACED IN THE LEFT BRACHIAL VEIN. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764640 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963257. One submission often covers many models, so check the product and lot details in each record.

• Z-2385-2018 · May 17, 2018 · Terminated
  Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utiliz