DLP™ 77014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000091136), received between Sep 25, 2024 and Sep 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Dec 12, 2024Open, Classified

   Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

   Z-0984-2025 · Root cause: Packaging · FDA record ↗

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.

• MalfunctionSep 2, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF THE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, THE PLASTIC MANDREL DID NOT REACH THE TIP OF THE CANNULA, WHICH MADE CANNULATION OF THE AORTA DIFFICULT. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931776 ↗
• MalfunctionSep 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA WAS FOUND TO BE MARKED AS A 14FR AND WAS INDEED IN A BOX LABELLED 14FR, HOWEVER THE ACTUAL SIZE OF THE DEVICE WAS 12FR. THE MANDREL WAS INDEED 14FR. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299651 ↗

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