DLP Aortic Root Cannula with Flow-Guard IntroducerRecalls & reported problems across all models

We found 2 models of DLP Aortic Root Cannula with Flow-Guard Introducer by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2024 and Jan 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

DLP Aortic Root Cannula with Flow-Guard Introducer recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 5, 2025Class IOpen, Classified

   Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).

   Z-1306-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

Most reported DLP Aortic Root Cannula with Flow-Guard Introducer problems

DLP Aortic Root Cannula with Flow-Guard Introducer models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DLP® Aortic Root Cannula with Flow-Guard™ Introducer 21012

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall2 reports
• DLP® Aortic Root Cannula with Flow-Guard™ Introducer 21014

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports

Recent DLP Aortic Root Cannula with Flow-Guard Introducer adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2025Crack; Material Separation; Crack; Material Separation

  IT WAS REPORTED THAT DURING THE PRE-OPERATIVE INSPECTION OF A DLP AORTIC ROOT CANNULA WITH A VENT LINE, THE PLASTIC RETAINING NODULES THAT HOLD THE INSERTION NEEDLE INSIDE THE CANNULA WERE FOUND BROKEN OFF INSIDE THE BLUE CONNECTOR. THERE WAS NO DAMAGE TO ANY PACKAGING AND NO VISIBLE DAMAGE TO OTHER PARTS OF THE CANNULA. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079264 ↗
• MalfunctionAug 8, 2024Material Separation; Material Deformation; Material Separation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA, IT WAS REPORTED THAT WHEN CANNULA WAS OPENED THE PLASTIC TIP WAS DAMAGED AND THE NEEDLE WAS LOOSE.THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937146 ↗

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