DLP® 77108Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994879947), received between Mar 6, 2018 and Mar 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 6, 2018Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PAEDIATRIC ONE-PIECE ARTERIAL CANNULA APPROXIMATELY 27 MINUTES AFTER FIRST USE OF THE CANNULA THE ANAESTHETIST NOTICED THE PRESENCE OF BLOOD COMING FROM A SPLIT IN THE CANNULA. A CUPULA WAS IMPLEMENTED UNDER THE CANULA TO RECOVER LOST BLOOD. IT IS UNKNOWN IF THE CANNULA WAS REPLACED. THE PATIENT EXPERIENCE HYPOVOLEMIA.

  Patient problems: Hypovolemia

  MAUDE report 7316323 ↗

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)