DLP® 31001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20613994575313), received between Mar 5, 2026 and Mar 5, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K810820); 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. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1796-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP I.M.A. CANNULAE, IT WAS REPORTED THAT INSTEAD OF HAVING A ROUNDED, ATRAUMATIC TIP, THE CANNULAE HAD A SHARP ELEMENT AT THE DISTAL END. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517946 ↗
• MalfunctionMar 5, 2026Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP I.M.A. CANNULAE, IT WAS REPORTED THAT INSTEAD OF HAVING A ROUNDED, ATRAUMATIC TIP, THE CANNULAE HAD A SHARP ELEMENT AT THE DISTAL END. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517920 ↗
• MalfunctionMar 5, 2026Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP I.M.A. CANNULAE, IT WAS REPORTED THAT INSTEAD OF HAVING A ROUNDED, ATRAUMATIC TIP, THE CANNULAE HAD A SHARP ELEMENT AT THE DISTAL END. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517831 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K810820. One submission often covers many models, so check the product and lot details in each record.

• Z-1799-2024 · Mar 19, 2024 · Open, Classified
  Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP 3 mm Vessel Cannula Blunt Tip, Model Number 30003
• Z-1316-2024 · Feb 7, 2024 · Open, Classified
  Medtronic DLP Vessel Cannula, Model Number REF 30000