DLP® 80120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994742531), received between Jul 6, 2021 and Jul 6, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K840002); 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 16, 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 6, 2021Material Separation; Material Deformation; Material Separation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 80120 DLP METAL TIP ARTERIAL CANNULA, THE CUSTOMER OBSERVED THAT THE METAL TIP DISSOCIATED FROM THE PLASTIC DURING DECANNULATION. THE TIP WAS RECOVERED WITHOUT HARM TO THE PATIENT. BLEEDING DURING THE CASE WAS OBSERVED BUT NOT VERY NOTABLE. NO BLOOD TRANSFUSION WAS REQUIRED DUE TO BLOOD LOSS. THE TIP FULLY DETACHED AS THE CANNULA WAS ALMOST ALREADY OUT OF THE PATIENT. IT WAS NEAR THE SURFACE OF THE INCISION AND THE PHYSICIAN REMOVED IT USING THEIR HANDS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120021 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K840002. One submission often covers many models, so check the product and lot details in each record.

• Z-0986-2025 · Dec 12, 2024 · Open, Classified
  Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
• Z-1793-2024 · Mar 19, 2024 · Open, Classified
  Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220
• Z-1927-2008 · May 9, 2008 · Terminated
  Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers: CB81120 and CB87022.