MC2® 91228Recalls & reported problems
Medtronic, Inc. · CANNULA 91228 MC2 VEN 28/36FR 10PK 17L · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169463015), received between Jan 8, 2025 and Jan 8, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1805-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Crack1
Patient problems
- Hemodynamic instability1
- Hemorrhage/Blood Loss/Bleeding1
- Low Blood Pressure/ Hypotension1
- Ventricular Fibrillation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2025Crack; Crack
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC2 TWO STAGE VENOUS CANNULA, IT WAS REPORTED DURING A REPAIR OF AN ASCENDING THORACIC ANEURYSM PROCEDURE UNDER CARDIOPULMONARY BYPASS, THE CUSTOMER LOST THE VENOUS DRAINAGE, SECONDARY TO THE FRACTURE OF THE VENOUS CANNULA. THE SITUATION CAUSED A VASCULAR AND HEMODYNAMICS COLLAPSE FOR ABOUT 2 MINUTES. THE CUSTOMER WAS ABLE TO RESOLVE IT IN ABOUT 2 MINUTES. THE PATIENT BLED APPROXIMATELY 800ML BESIDE THE CARDIOVASCULAR COLLAPSE WITH SEVERE HYPOTENSION AND VENTRICULAR FIBRILLATION. THE USE OF THE DEVICE WAS UNSPECIFIED.
Patient problems: Hemodynamic instability; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Ventricular Fibrillation
MAUDE report 21105972 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.