ARROW IPN923010Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801902205404), received between May 20, 2024 and Feb 25, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THERE ARE TWO PRODUCTS INVOLVED IN THE COMPLAINT BY THE SAME INSERTER. DURING BOTH INSERTIONS, THE WIRE WAS SHEARED OFF INTO THE PATIENT. INTERVENTIONAL RADIOLOGY (IR) AND VASCULAR WERE CONSULTED FOR WIRE RETRIEVAL; HOWEVER, THE RETRIEVAL WAS UNSUCCESSFUL. THE PATIENT HAD AN INJURY, AND THE CONDITION OF THE PATIENT IS UNKNOWN. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00188.

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

  MAUDE report 21458766 ↗
• InjuryFeb 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THERE ARE TWO PRODUCTS INVOLVED IN THE COMPLAINT BY THE SAME INSERTER. DURING BOTH INSERTIONS, THE WIRE WAS SHEARED OFF INTO THE PATIENT. INTERVENTIONAL RADIOLOGY (IR) AND VASCULAR WERE CONSULTED FOR WIRE RETRIEVAL; HOWEVER, THE RETRIEVAL WAS UNSUCCESSFUL. THE PATIENT HAD AN INJURY, AND THE CONDITION OF THE PATIENT IS UNKNOWN. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00188 AND 9680794-2025-00187.

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

  MAUDE report 21458752 ↗
• MalfunctionAug 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "FOUR GUIDEWIRES HAVE ROUGH SPOTS ON THEM THAT CAUSE THEM TO NOT PASS WELL AND KINK OR BIND UPON ITSELF." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-00836, 9680794-2024-00835, 9680794-2024-00834, 9680794-2024-00833.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20094749 ↗
• MalfunctionAug 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "FOUR GUIDEWIRES HAVE ROUGH SPOTS ON THEM THAT CAUSE THEM TO NOT PASS WELL AND KINK OR BIND UPON ITSELF." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPOTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-00836, 9680794-2024-00835, 9680794-2024-00834, 9680794-2024-00833.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20094737 ↗
• MalfunctionAug 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "FOUR GUIDEWIRES HAVE ROUGH SPOTS ON THEM THAT CAUSE THEM TO NOT PASS WELL AND KINK OR BIND UPON ITSELF." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-00836, 9680794-2024-00835, 9680794-2024-00834, 9680794-2024-00833.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20094714 ↗
• MalfunctionAug 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "FOUR GUIDEWIRES HAVE ROUGH SPOTS ON THEM THAT CAUSE THEM TO NOT PASS WELL AND KINK OR BIND UPON ITSELF." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPOTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-00835, 9680794-2024-00834, 9680794-2024-00833.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20094700 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED, "WHITE TABS ON GLIDETHRU SHEATH BROKE OFF DURING MIDLINE INSERTION. PROCEDURE COMPLETED WITHOUT ANY DIFFICULTIES." THE SHEATH WAS REMOVED AND THE PROCEDURE WAS COMPLETED. 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 19606203 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED "GLIDETHRU SHEATH, WHITE HANDLES BROKE DURING INSERTION OF MIDLINE". 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 19477038 ↗
• MalfunctionMay 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "AFTER REMOVAL OF THE GUIDEWIRE, THE WIRE WAS TIED IN A KNOT." 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 19350397 ↗