PROTEK DUO+ 5150-5131Recalls & reported problems
Sorin Group Italia Srl · Class 2
- 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 08033178019422), received between Apr 29, 2026 and Apr 29, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2026Crack
LIVANOVA US RECEIVED REPORT OF A PROTEKDUO+ CANNULA WHICH WAS FOUND CRACKED DURING USAGE. REPORTEDLY, AIR INTAKE OCCURRED AND SUPPORT WAS RECONFIGURED. NO FURTHER ISSUE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031620 ↗
Other Dual lumen ECMO cannula devices
- MC3 Crescent Jugular Dual Lumen Catheter 70132Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula9 reports
- MC3 Crescent Jugular Dual Lumen Catheter 70128Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula5 reports
- MC3 Crescent RA Dual Lumen Catheter 15FR 70415Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 death4 reports
- MC3 Crescent Jugular Dual Lumen Catheter 70126Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 report
- MC3 Crescent(tm) Jugular Dual Lumen Catheter 70128Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 report
- MC3 Crescent(tm) Jugular Dual Lumen Catheter 70132Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 report
- MC3 Crescent Jugular Dual Lumen Catheter 70124Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 report
- MC3 Crescent RA Dual Lumen Catheter 13FR 70413Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 death1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.