Cardica C-Port Flex-A Plus Distal Anastomosis System FG-000150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 11814900001502), received between Dec 7, 2017 and Apr 13, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K073123); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2018Fracture; Material Rupture; Defective Component; Failure to Fire; Fracture; Material Rupture; Defective Component; Failure to Fire

  THE C-PORT FLEX-A DEVICE WAS PREPARED WITH A VEIN GRAFT. THE PA ASSISTING IN THE PROCEDURE ACTIVATED THE C-PORT BY TURNING THE KNOB. UPON TURNING THE KNOB THE DEVICE BROKE INTO PIECES THAT SCATTERED AND WAS ACCOMPANIED BY A LOUD NOISE. THERE WAS NO REPORTED ADVERSE EVENT EITHER TO THE PATIENT OR TO USER/SURGICAL PERSONNEL.

  Patient problems: Not Applicable

  MAUDE report 7431368 ↗
• MalfunctionApr 9, 2018Fracture; Material Rupture; Defective Component; Failure to Fire; Fracture; Material Rupture; Defective Component; Failure to Fire

  DURING DEPLOYMENT OF THE DEVICE AND WHILE BEING HELD BY THE SURGEON, THE DEVICE HANDLE BROKE INTO PIECES, ACCOMPANIED BY A LOUD NOISE. THERE WAS NO REPORTED ADVERSE EVENT EITHER TO THE PATIENT OR TO USER/SURGICAL PERSONNEL.

  Patient problems: Not Applicable

  MAUDE report 7410270 ↗
• MalfunctionDec 7, 2017Retraction Problem; Device Dislodged or Dislocated; Retraction Problem; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT A ROBOTIC TECAB PROCEDURE IN WHICH THE C-PORT DEVICE WAS USED TO PERFORM THE DISTAL BYPASS ANASTOMOSIS. THE DEVICE FUNCTIONED AS INTENDED AND THE PROCEDURE WAS COMPLETED AS INTENDED. FOLLOWING A POST-OPERATIVE CHEST X-RAY, A SMALL METALLIC DENSITY WAS NOTED IN THE PATIENT'S LEFT CHEST THAT WAS PREVIOUSLY NOT RECOGNIZED. AFTER SURGERY, THE PATIENT WAS TRANSFERRED FOR NORMAL POSTOPERATIVE CARE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THE METALLIC DENSITY.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 7098161 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073123. One submission often covers many models, so check the product and lot details in each record.

• Z-2434-2018 · Apr 2, 2018 · Terminated
  AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips