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Arterial Cannula A212-65CRecalls & reported problems

Sorin Group Italia Srl · Class 2

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 08033178000642), received between Jun 20, 2019 and Jun 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (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.

Most reported problems

Device problems

  • Disconnection1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 20, 2019Disconnection; Disconnection

    SORIN GROUP (B)(4) HAS BEEN INFORMED THAT UPON INSERTION OF THE ARTERIAL CANNULA, THE CAP AT THE END OF THE CANNULA FELL OFF AND BLOOD FLOWED ONTO THE SURGEON. THERE IS NO REPORT OF ANY PATIENT/USER INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8716670 ↗

Other CANNULA, CATHETER devices

All CANNULA, CATHETER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.