INPUT™ TS 091102ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169014077), received between Oct 23, 2018 and Oct 23, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 23, 2018Use of Device Problem; Use of Device Problem

  A 9F INPUT TS WAS USED DURING A PROCEDURE. IT IS REPORTED THAT THE DEVICE WAS USED BEYOND THE EXPIRY DATE. ON (B)(6) 2018 THE COMPANY WAS NOTIFIED THROUGH A DISTRIBUTOR THAT PROVIDED THE PRODUCT WITH AN EXPIRATION DATE OF THE (B)(6) 2018 WAS USED IN PATIENT SURGERY. AT THE MOMENT OF THE INVOICE, THE HOSPITAL BECOME AWARE THAT THE PRODUCT WAS NON-CONFORMING -THE PRODUCT WAS DELIVERED EXPIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7994709 ↗

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-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
• 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-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-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