DLP™ 77016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000091143), received between Jul 5, 2023 and Oct 18, 2023 — classified as 2 malfunctions.

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

• MalfunctionOct 18, 2023Material Puncture/Hole; Packaging Problem; Material Puncture/Hole; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THE CANNULA HAD A DAMAGED INTRODUCER. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER BELIEVES THE INTRODUCER IS TOO SHORT. THERE WAS DAMAGE TO THE PACKAGING, SPECIFICALLY THE INNER PACKAGING/STERILE BARRIER. NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER ALSO DAMAGED. IT WAS CONFIRMED THAT THE DEVICE WAS NOT TO BE USED AFTER THE EXPIRATION DATE SHOWN ON THE LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17955857 ↗
• MalfunctionJul 5, 2023Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CANNULA THE CUSTOMER NOTICED THAT THE CANNULA HAD INDENTATIONS AND THE CUSTOMER HAD DIFFICULTY TO SMOOTHLY REMOVE THE INTRODUCER. THE CUSTOMER STATED THAT THIS OCCURRED AFTER THE OPERATION AND THE CANNULA HAD BEEN USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION CONFIRMED THAT THE SHEATH REMOVAL ISSUE WAS OBSERVED WHEN THE CANNULA WAS BEING REMOVED FROM THE PATIENT, THE REMOVAL OF THE SHEATH TUBE WAS OBSTRUCTED. THE BLUE INTRODUCER HANDLE WAS NOT TAKEN OFF DIRECTLY, BUT RESISTANCE APPEARED WHEN THE SHEATH WAS REMOVED, AND IT FELL WHEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262561 ↗

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)