INPUT™ PS 070011Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169014589), received between May 10, 2018 and Nov 1, 2019 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 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 9265328 ↗
• MalfunctionMay 24, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN EXPIRED INPUT INTRODUCER KIT WAS OPENED AT THE ACCOUNT AND USED IN A PATIENT. THE DEVICE WAS BEING USED FOR VENOUS ACCESS. IT WAS REPORTED THAT THERE WAS NO TORTUOSITY OR CALCIFICATION. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE PATIENT ANATOMY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE WAS PROPERLY HYDRATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639803 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SUFFERED ANAPHYLAXIS DURING CARDIAC ABLATION. IT IS INDICATED THAT THE EVENT IS SECONDARY TO THE INPUT PS INTRODUCER SHEATHS USED IN THE PROCEDURE.

  Patient problems: Anaphylactic Shock

  MAUDE report 7591135 ↗
• InjuryMay 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO INPUT PS INTRODUCER SHEATHS WERE USED DURING A CARDIAC ABLATION. PATIENT SUFFERED ANAPHYLAXIS. THERE IS A POSSIBILITY THAT THE PATIENT WAS ALLERGIC TO ETHYLENE OXIDE USED TO STERILISE THE DEVICES.

  Patient problems: Anaphylactic Shock

  MAUDE report 7524979 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT SUFFERED ANAPHYLAXIS DURING CARDIAC ABLATION. IT IS INDICATED THAT IT IS LIKELY TO BE SECONDARY TO THE 7F INPUT INPUT PS INTRODUCER SHEATH USED IN THE PROCEDURE.

  Patient problems: Anaphylactic Shock

  MAUDE report 7502338 ↗