INPUT™ PS 080011Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169014510), received between May 18, 2018 and Oct 25, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AN 8F INPUT INTRODUCER WAS ATTEMPTED TO BE USED. NO DAMAGE NOTED TO PACKAGING. NO ISSUES REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITHOUT ISSUE. NO RESISTANCE WAS NOTED WHEN ATTEMPTING TO REMOVE THE INTRODUCER FROM THE SHEATH. NO RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE DILATOR INTO THE SHEATH DURING PREP. IT IS REPORTED THAT THE SHEATH OF THE DEVICE CRACKED AT THE END OF THE PROCEDURE, AS THE OPERATOR WAS PULLING BACK THE DEVICE. THE DEVICE WAS NOT BENT EXCESSIVELY PRIOR TO THE DETACHMENT. A PORTION OF THE DEVICE REMAINED IN THE ARTERY. A SURGEON WAS CALLED TO REMOVE THE REMAINING PIECE OF THE DEVICE FROM THE ARTERY. THE PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO FURTHER INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8003684 ↗
• InjuryJun 11, 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 INPUT INPUT PS INTRODUCER SHEATHS USED IN THE PROCEDURE.

  Patient problems: Anaphylactic Shock

  MAUDE report 7586642 ↗
• InjuryJun 11, 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 INPUT PS INTRODUCER SHEATHS USED IN THE PROCEDURE.

  Patient problems: Anaphylactic Shock

  MAUDE report 7586606 ↗
• 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 7524988 ↗