VENO-VENOUS PROTEK DUO+ CANNULA
Received Apr 29, 2026 · Event occurred Jan 9, 2026
Report 1718850-2026-10004 · MDR key 25031620
Device
Generic name
Dual Lumen Ecmo Cannula
Manufacturer
Sorin Group ItaliaModel number
31FRCatalog number
5150-5131
Lot number
489078
Product problems
- Crack
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. F14: UPDATED MANUFACTURER NAME AND ADDRESS TO SORIN GROUP ITALIA [9680841]. H11: THROUGH FOLLOW-UP COMMUNICATIONS, LIVANOVA LEARNED THAT THE CANNULA WAS USED FOR FIVE (5) DAYS. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
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.