DLP™ CB67312Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000192525), received between Nov 16, 2022 and Nov 16, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionNov 16, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 12 FR DLP CARMEDA VENOUS CANNULA WITH A RIGHT-ANGLE METAL TIP, IT WAS REPORTED THAT WHEN THE SURGEON WAS CANNULATING THE PATIENT, BLOOD WAS NOTICED TO BE COMING OUT OF A HOLE ON THE PROXIMAL DORSAL SIDE OF THE CANNULA. WHEN THE CANNULA WAS REMOVED AND INSPECTED, IT WAS NOTICED THAT THERE WAS A SMALL HOLE IN THE CANNULA. THERE WAS MINIMAL BLOOD LOSS. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15803624 ↗

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;