INPUT™ PS 050011Recalls & reported problems
Medtronic, Inc. · INTRDCR 050011 5PK 5F 11CM INPT INTR KIT · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169014336), received between Nov 1, 2019 and Nov 1, 2019 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Anaphylactic Shock1
- Reaction1
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 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 9265298 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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