Cannula Graft™ CGS2008SRecalls & reported problems
Vascutek Ltd · Cannula Graft PVC Cannula with Gelatin Sealed ePTFE Vascular Prosthesis · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881009537), received between Dec 21, 2016 and Sep 19, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Leak/Splash2
- Loss of or Failure to Bond1
- Material Integrity Problem1
Patient problems
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2017Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem
THE EVENT WAS REPORTED TO VASCUTEK AS FOLLOWS: CANNULA GRAFT WAS LEAKING AND WEEPING FLUID. PATIENT CONVERTED ONTO FULL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WITH CANNULA STILL IN PLACE. - DELAY IN MEDICAL PROCEDURE HOWEVER NO REPORTED PATIENT EFFECT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6875048 ↗MalfunctionDec 21, 2016Loss of or Failure to Bond; Leak/Splash; Loss of or Failure to Bond; Leak/Splash
THE EVENT WAS DESCRIBED TO VASCUTEK ON 23-NOV-16 AS FOLLOWS: A LINEAR CRACK WAS NOTICED IN CANNULA CONNECTOR. AFTER THE DEVICE WAS CONNECTED AND FLOW ESTABLISHED THE CANNULA WAS FOUND TO BE LEAKING AT THE CRACK SITE, IT WAS APPROX. 1CM, OR LESS, FROM THE LUER CAP ON THE CONNECTOR. A STERILE BAND WAS USED TO COVER THE AREA AND PREVENT ACTIVE LEAK. A SMALL LEAK REMAINED BUT THE CASE WAS COMPLETED. NO EFFECT ON PATIENT, CANNULA WAS REMOVED WHEN PATIENT WAS TAKEN OFF BYPASS AS PER NORMAL PROCEDURE. ON 28TH NOV 2016 FURTHER INFORMATION WAS RECEIVED FROM THE HOSPITAL THAT THE LEAKAGE WAS DUE TO POOR CONNECTION BETWEEN PLASTIC TUBE (PVC) AND LUER LOCK CONNECTOR RATHER THAN CRACK IN CONNECTOR.
Patient problems: No Information
MAUDE report 6192547 ↗
Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices
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- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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