ARROW IPN926112Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902211481), received between Sep 1, 2022 and Sep 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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

1 other recall cover devices cleared under the same FDA submission (K945229); 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-2366-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT "THE BLADDER FEATURE PIECES CAME APART WITH THE WIRE IN THE VENTRICLE". ADDITIONAL INFORMATION RECEIVED STATED THAT "A NEW KIT AND WIRE HAD TO BE OPENED/FLOATED. NO INJURY TO THE PATIENT. WE OPENED A THIRD KIT TO TAKE APART THE BLADDER COMPONENTS TO MAKE SURE ALL OF THEM WERE PRESENT IN THE BLADDER THAT CAME APART WHILE ATTACHED TO THE PATIENT. PATIENT IS RECOVERED FROM CARDIAC SURGERY. PATIENT WAS A RE-OP VALVE THROUGH A MINI INCISION". PATIENT CONDITION REPORTED AS "FINE". ASSOCIATED MDR 3010532612-2022-00342.

  Patient problems: Insufficient Information

  MAUDE report 15341657 ↗
• MalfunctionSep 1, 2022Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT "THE BLADDER FEATURE PIECES CAME APART WITH THE WIRE IN THE VENTRICLE". ADDITIONAL INFORMATION RECEIVED STATED THAT "A NEW KIT AND WIRE HAD TO BE OPENED/FLOATED. NO INJURY TO THE PATIENT. WE OPENED A THIRD KIT TO TAKE APART THE BLADDER COMPONENTS TO MAKE SURE ALL OF THEM WERE PRESENT IN THE BLADDER THAT CAME APART WHILE ATTACHED TO THE PATIENT. PATIENT IS RECOVERED FROM CARDIAC SURGERY. PATIENT WAS A RE-OP VALVE THROUGH A MINI INCISION". PATIENT CONDITION REPORTED AS "FINE". ASSOCIATED MDR 3010532612-2022-00339.

  Patient problems: Insufficient Information

  MAUDE report 15341474 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K945229. One submission often covers many models, so check the product and lot details in each record.

• Z-3197-2018 · Jul 30, 2018 · Terminated
  ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in elec