Arterial cardiopulmonary bypass cannula RA-xxxxx (UDI 00803622105012)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00803622105012), received between Jul 19, 2017 and Jul 19, 2017 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K943934); they may or may not involve this specific model.

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

Recent adverse event reports

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

• InjuryJul 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SORIN GROUP RECEIVED A REPORT THAT AN AORTIC TEAR RESULTING IN GREATER THAN 1000ML OF BLOOD LOSS OCCURRED DURING DECANNULATION OF THE AORTIC ARCH CANNULA. THE PATIENT SURVIVED WITH NO OTHER COMPLICATIONS. THE CUSTOMER REPORTED THAT THE CAUSE OF THE TEAR COULD NOT BE DETERMINED BY THE SURGEON.

  Patient problems: Excessive Tear Production

  MAUDE report 6726339 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K943934. One submission often covers many models, so check the product and lot details in each record.

• Z-2871-2017 · Jun 9, 2017 · Terminated
  Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during c
• Z-2756-2016 · Aug 12, 2016 · Terminated
  Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during c
• Z-2147-2016 · Jun 22, 2016 · Terminated
  AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracor
• Z-0813-2016 · Jan 25, 2016 · Terminated
  Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) po