DLP™ 77012 (UDI 20763000091129)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000091129), received between Nov 16, 2022 and Jun 30, 2023 — classified as 2 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K024069); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE BEFORE PLACING THE PEDIATRIC ONE-PIECE ARTERIAL CANNULA IN THE AORTA, THE WIRE WINDING OF THE CANNULA SEEMED TO BE SEPARATED FROM THE PVC BODY. WHEN THEY TRIED TO FIX IT WITH A SNARE, THE CANNULA BROKE. THEY USED A NEW 77012 CANNULA INSTEAD AND THERE WAS NO PROBLEM. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFO- IT WAS NOTICED THAT THE WIRE WINDING WAS BROKEN PRIOR TO INSERTION OF THE CANNULA INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237077 ↗
• MalfunctionNov 16, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE PIECE ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THE CANNULA STYLET WAS NOTED TO BE BROKEN WHEN THE PACKET WAS OPENED. USE OF THE DEVICE WAS REQUESTED BUT IT WAS REPORTED AS ASKED BUT UNKNOWN. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803538 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K024069. One submission often covers many models, so check the product and lot details in each record.

• Z-2738-2026 · May 25, 2026 · Open, Classified
  Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
• Z-0984-2025 · Dec 12, 2024 · Open, Classified
  DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)