ARROW IPN923011Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10801902205411), received between Oct 2, 2023 and Nov 5, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

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

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "INTRODUCER NEEDLE HUB (PLASTIC) PULLED OFF OF NEEDLE SHAFT". THE NEEDLE SHAFT WAS PULLED FROM THE SKIN OVER THE WIRE AND THE CATHETER WAS SUCCESSFULLY INSERTED. 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 23477160 ↗
• MalfunctionMar 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE MIDLINE DRESSING WAS FILLING WITH BLOOD. THE DRESSING WAS CHANGED. LATER, UPON FLUSHING IT WAS REALIZED THAT THE CATHETER WAS LEAKING WHERE IT MEETS THE HUB. THE PATIENT HAD TO GET A NEW CATHETER.". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688891 ↗
• MalfunctionMar 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "WITHOUT MUCH FORCE, THE MIDLINE EXTENSION BROKE FREE OF THE CATHETER. THE PATIENT HAD TO GET A NEW CATHETER." THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688797 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT: "THE WINGS ARE BREAKING OFF AS THE SHEATH IS BEING REMOVED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINT 9680794-2025-00061.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136493 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT: "THE WINGS ARE BREAKING OFF AS THE SHEATH IS BEING REMOVED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINT 9680794-2025-00060.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136475 ↗
• MalfunctionOct 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "OUR PICC NURSE OPENED THE MIDLINE KIT FOR PROCEDURE AND FOUND THE PROBE COVER HAD A TEAR IN IT." ADDITIONAL INFORMATION RECEIVED REPORTS THE TRANSDUCER COVER HAD THE TEAR INSTEAD. THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350461 ↗
• MalfunctionJun 10, 2024Material Separation; Material Separation

  IT WAS REPORTED: "HANDLE OF PEEL AWAY BROKE OFFPEEL AWAY WAS RETRIEVED" 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 19498462 ↗
• MalfunctionFeb 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: MIDLINE LEAKING AT INSERTION SITE. MULTIPLE DRESSING CHANGES NEEDED. CLINICAL EDUCATION MANAGER GAVE EDUCATION ON MIDLINES, CATHETER TO VESSEL RATIO, PROPER INFUSATES AND CARE AND MAINTENANCE. 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 18666477 ↗
• MalfunctionFeb 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MIDLINE LEAKING AT INSERTION SITE. MULTIPLE DRESSING CHANGES NEEDED. CLINICAL EDUCATION MANAGER GAVE EDUCATION ON MIDLINES, CATHETER TO VESSEL RATIO, PROPER INFUSCATE AND CARE AND MAINTENANCE. VAT NURSE PLANNING TO REMOVE CATHETER AND INSERT A NEW CATHETER SO PATIENT COULD BE DISCHARGED TO NURSING FACILITY. I REQUESTED THEY SAVE THE CATHETER FOR RETURN. 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 18666420 ↗
• MalfunctionOct 20, 2023Material Separation; Material Twisted/Bent; Material Too Soft/Flexible; Material Separation; Material Twisted/Bent; Material Too Soft/Flexible

  IT WAS REPORTED THAT: GLIDE THRU PEEL AWAY SHEATH BROKE AT THE HANDLE, ON THE PROXIMAL PORTION OF THE SHEATH. THE MATERIAL FELT THINNER AND SOFTER ON ONE SIDE. THE NURSE USED HER FINGERS TO CAREFULLY SEPARATE AND PEEL AWAY THE REMAINING SHEATH BODY. SHE WAS ABLE TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION: THE INSERTION SITE WAS UPPER ARM. THE PATIENT SKIN WAS REPORTED AS TOUGH. THE PEEL AWAY BUCKLED AT THE TIP LEADING INTO THE SKIN. 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 17974986 ↗
• MalfunctionOct 12, 2023Break; Break

  IT WAS REPORTED THE GLIDE-THRU PEEL-AWAY SHEATH WOULD NOT PEEL CORRECTLY AND A PORTION BROKE OFF. USER REPORTS THE THE PEEL-AWAY FEELS THIN AND FLIMSY. THE SHEATH WAS REMOVED IN ITS ENTIRETY AND PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921867 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: GLIDE THRU PEEL AWAY SHEATH BROKE AT THE HANDLE, ON THE PROXIMAL PORTION OF THE SHEATH. THE NURSE USED HER FINGERS TO CAREFULLY SEPARATE AND PEEL AWAY THE REMAINING SHEATH BODY. SHE WAS ABLE 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. ADDITIONAL INFORMATION: THE INSERTION SITE WAS IN THE UPPER ARM. THE ENTIRE SHEATH WAS CONFIRMED TO HAVE BEEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850702 ↗