DLP® 69316Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20199150022056), received between Apr 23, 2026 and Apr 23, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

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. 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.

• MalfunctionApr 23, 2026Obstruction of Flow

  IT WAS REPORTED THAT DURING APPROXIMATELY 3 HOURS OF CANNULATION WITH THE DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT ANGLE METAL TIP, A CLOTTING ISSUE WAS OBSERVED. NO DAMAGE TO THE CANNULA BODY OR TIP WAS IDENTIFIED. HEPARIN WAS THE ANTICOAGULANT THAT WAS USED. 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 24963285 ↗

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;