Aortic-Root Cannula R501-26Recalls & reported problems
Sorin Group Italia Srl · Class 2
Data updated Oct 16, 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 08033178004053), received between Aug 3, 2021 and Aug 3, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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 16, 2026.
Most reported problems
Device problems
- Disconnection2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2021Disconnection; Disconnection
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12267151 ↗MalfunctionAug 3, 2021Disconnection; Disconnection
SEE INTIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12267125 ↗
Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- 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 HY11R00R6Medtronic, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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