Venous cardiopulmonary bypass cannula LR-xxxxx (UDI 00803622104053)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00803622104053), received between Jul 13, 2017 and Jul 13, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Flaked” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2017Flaked; Flaked

  SORIN GROUP RECEIVED A REPORT THAT THE INK PRINTED ON THE SIDE OF THE AORTIC ARCH CANNULAE BEGAN TO FLAKE OFF INTO THE SURGICAL AREA DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6709865 ↗

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