Arterial cardiopulmonary bypass cannula RA-xxxxx (UDI 00803622105043)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00803622105043), received between Mar 24, 2017 and Jun 7, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2017Device Issue; Device Issue

  SORIN GROUP RECEIVED A REPORT THAT THE VENT LUER CONNECTOR AND THE TIP OF THE AORTIC ARCH CANNULA WERE FOUND TO NOT ON THE SAME PLANE DURING SETUP. THEY WERE AT 120 DEGREES INSTEAD OF 180 DEGREES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6618668 ↗
• MalfunctionMar 24, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  SORIN GROUP RECEIVED A REPORT THAT THE AORTIC ARCH CANNULA DISCONNECTED SUDDENLY FROM THE TIP THAT WAS INSERTED INTO THE AORTA DURING A PROCEDURE. THE CANNULA WAS CHANGED TO CONTINUE THE OPERATION. THE USER REPORTED SIGNIFICANT BLEEDING. HOWEVER, THERE WAS NO ADDITIONAL CONSEQUENCE OF THE BLEEDING AND NO OTHER PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6432970 ↗

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