DLP™ 77012 (UDI 20763000946696)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20763000946696), received between Mar 4, 2026 and Mar 4, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Misassembled During Installation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 4, 2026Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THE OBTURATOR WAS TOO SHORT FOR CANNULA. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510884 ↗

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)