MC2® 91265Recalls & reported problems
Medtronic, Inc. · CANNULA 91265 MC2 VEN OVAL 36/46FR · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994887416), received between Dec 18, 2025 and Dec 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
- Delivered as Unsterile Product1
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.
MalfunctionDec 18, 2025Contamination; Delivered as Unsterile Product; Contamination; Delivered as Unsterile Product
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MC2 TWO STAGE VENOUS CANNULA, IT WAS REPORTED THE PACKAGING WAS DAMAGED. THE DEVICE WAS REPLACED WITH 91265 CANNULA. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A HOLE IN THE OUTER PACKAGING OF THE CANNULA. THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE PRODUCT WAS NOT USED. THE STERILE SEAL WAS INTACT. THE DEVICE WAS SEALED/LOCATED IN THE 'SEAL'. THE PACKAGE IS UNOPENED AND CANNOT BE CONFIRMED IF THERE WAS FOREIGN MATERIAL (FM) PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23841843 ↗
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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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