INPUT™ TS 051102ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169014442), received between Apr 24, 2020 and May 7, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Defective 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2021Leak/Splash; Leak/Splash

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE 5 FRENCH INPUT INTRODUCER TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT A LEAK OCCURRED. IT WAS STATED THAT THE INTRODUCER WAS LEAKING, LEADING TO AN EXTENSIVE HEMATOMA ON THE PATIENT'S LEG. ALTHOUGH THE HOSPITALIZATION CARE WAS EXTENDED NO INTERVENTION WAS REPORTED AND THE HEMATOMA WAS ONLY TEMPORARY.

  Patient problems: Hematoma; Unspecified Tissue Injury

  MAUDE report 11790975 ↗
• InjuryApr 24, 2020Difficult to Insert; Defective Component; Difficult to Insert; Defective Component

  AN 11CM, 5F INPUT TS INTRODUCER W/NEEDLE AND GUIDEWIRE WAS ATTEMPTED TO BE USED DURING A PROCEDURE FOR THROMBUS ASPIRATION OF PULMONARY EMBOLISM AND INFERIOR VENA CAVA FILTER PLACEMENT. IT WAS REPORTED THAT WHEN THE GUIDE WIRE WAS PLACED AND THE CATHETER SHEATH WAS BEING PLACED ALONG THE GUIDE WIRE, THE GUIDE WIRE COULD NOT PASS THROUGH THE CATHETER SHEATH. THIS CAUSED THE OPERATION TO BE SUSPENDED AND ANOTHER NON-MEDTRONIC ARTERY SHEATH WAS USED INSTEAD TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE GUIDE WIRE DID NOT MATCH THE SHEATH, OR THE SHEATH INNER DIAMETER WAS TOO NARROW. IT WAS REPORTED THAT THE PATIENT INJURY STATUS WAS SERIOUS INJURY.

  Patient problems: Injury

  MAUDE report 9994823 ↗

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-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-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