INPUT™ TS 051101ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169014305), received between Dec 2, 2020 and Dec 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K955785); 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE 5 FRENCH ENHANCED INSERT INPUT TS INTRODUCER SHEATH TO TREAT A PERIPHERAL LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS PROPERLY HYDRATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE SHEATH WAS BROKEN DURING RETRIEVAL FROM PATIENT UPON CLOSURE OF OPERATION. IT WAS STATED THAT THE PATIENT ENDED UP GOING FOR OPEN SURGERY TO TAKE OUT THE SHEATH FROM PATIENT'S BODY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10934310 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955785. One submission often covers many models, so check the product and lot details in each record.

• Z-0443-2009 · Oct 7, 2008 · Terminated
  7 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 070A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilita
• Z-0441-2009 · Oct 7, 2008 · Terminated
  5 F BardSelect 11 cm Percutaneous Catheter Introducer Set Ref: 050A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilita
• Z-0442-2009 · Oct 7, 2008 · Terminated
  6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilita
• Z-0444-2009 · Oct 7, 2008 · Terminated
  Medtronic Input TS 7F 11 cm Ref: 071102A Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter throug