INPUT™ PS 060011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169014657), received between Nov 1, 2019 and Nov 1, 2019 — classified as 2 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOUR INPUT INTRODUCERS SHEATHS WERE USED DURING AN ELECTROPHYSIOLOGIC PROCEDURE. TWO 6 FR SHEATHS, ONE 5 FR SHEATH AND ONE 7FR SHEATH WERE PLACED WITHOUT COMPLICATION. IT WAS REPORTED THAT IMMEDIATELY AFTER FLUSHING THE SHEATHS AND INTRODUCING AN ELECTROPHYSIOLOGIC CATHETER THE PATIENT SUFFERED AN ANAPHYLACTOID REACTION CHARACTERISED BY PROFOUND HYPOTENSION, TACHYCARDIA, DISTRESSED BREATHING AND URTICARIAL SKIN REACTION. THE PATIENT WAS STABILIZED. RECOVERY WAS PROMPT AND THE PATIENT PROCEEDED TO HAVE THE ELECTROPHYSIOLOGIC PROCEDURE UNDERTAKEN. POST PROCEDURE THE PATIENT HAD A STROKE. THE PATIENT HAS SINCE RETURNED TO WORK BUT HAS IMPAIRMENT TO ONE ARM. IT WAS QUERIED IF THE DEVICE CONTAINED LATEX AS THE HOSPITAL ARE TRYING TO ESTABLISH WHAT CAUSED THE REACTION.

  Patient problems: Anaphylactic Shock; Reaction; Stroke/CVA

  MAUDE report 9265316 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOUR INPUT INTRODUCERS SHEATHS WERE USED DURING AN ELECTROPHYSIOLOGIC PROCEDURE. TWO 6 FR SHEATHS, ONE 5 FR SHEATH AND ONE 7FR SHEATH WERE PLACED WITHOUT COMPLICATION. IT WAS REPORTED THAT IMMEDIATELY AFTER FLUSHING THE SHEATHS AND INTRODUCING AN ELECTROPHYSIOLOGIC CATHETER THE PATIENT SUFFERED AN ANAPHYLACTOID REACTION CHARACTERISED BY PROFOUND HYPOTENSION, TACHYCARDIA, DISTRESSED BREATHING AND URTICARIAL SKIN REACTION. THE PATIENT WAS STABILIZED. RECOVERY WAS PROMPT AND THE PATIENT PROCEEDED TO HAVE THE ELECTROPHYSIOLOGIC PROCEDURE UNDERTAKEN. POST PROCEDURE THE PATIENT HAD A STROKE. THE PATIENT HAS SINCE RETURNED TO WORK BUT HAS IMPAIRMENT TO ONE ARM. IT WAS QUERIED IF THE DEVICE CONTAINED LATEX AS THE HOSPITAL ARE TRYING TO ESTABLISH WHAT CAUSED THE REACTION.

  Patient problems: Anaphylactic Shock; Reaction; Stroke/CVA

  MAUDE report 9265310 ↗