DLP® 69331 (UDI 20199150021998)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20199150021998), received between Sep 29, 2026 and Sep 29, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K120988); 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.

• MalfunctionSep 29, 2026Material Puncture/Hole

  It was reported that prior to use, the DLP Single Stage Venous Cannula with Right Angle Metal Tip was opened and its tip appeared sharp where the holes were drilled. The cannula was not used and was replaced with another product. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928661 ↗
• MalfunctionSep 29, 2026Material Puncture/Hole

  It was reported that, upon opening the DLP Single Stage Venous Cannula with Right Angle Metal Tip prior to use, the cannula tip at the drilled holes felt sharp. The cannula was not used and was replaced with a Medtronic product. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928436 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120988. One submission often covers many models, so check the product and lot details in each record.

• Z-3128-2024 · Jul 9, 2024 · Open, Classified
  Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
• Z-0908-2013 · Feb 19, 2013 · Terminated
  Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312;