DLP® Aortic Root Cannula with Flow-Guard™ 11012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20613994495451), received between Oct 9, 2024 and Feb 9, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

2 FDA recall records name this device's identifier, 2 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, 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.

Recalls naming this device

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 · Recall details · FDA record ↗

2. Oct 3, 2024Class IIOpen, Classified

   There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

   Z-0289-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA, IT WAS REPORTED THAT UPON INSPECTION BEFORE USE, THE NEEDLE WAS FOUND TO BE BENT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS KINKED. THE PUMP WAS LOCATED ON THE RIGHT SIDE OF THE PATIENT. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292866 ↗
• MalfunctionJan 23, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA, IT WAS REPORTED THAT THE DEVICE HAD DIFFICULTY LOCKING PROPERLY. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219285 ↗
• MalfunctionJan 13, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A MINIMALLY INVASIVE AORTIC ROOT CANNULA THERE WAS AN ALLEGED PRODUCT ISSUE, AS THE STYLET COULD NOT LOCK. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136478 ↗
• MalfunctionDec 6, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA, IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO LOCK. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864618 ↗
• MalfunctionOct 9, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA, IT WAS REPORTED THAT THE PACKAGE WAS OPEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE SEAL WAS NOT INTACT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER HAS MORE DEVICES FROM THE COMPLAINT LOT AT THEIR FACILITY; HOWEVER, THEY DID NOT OBSERVE THIS ISSUE WITH ANY OF THE OTHER DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20405726 ↗