DLP™ CB67532Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000192617), received between Jul 25, 2022 and Jul 25, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Air/Gas in Device” (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.

• InjuryJul 25, 2022Fracture; Air/Gas in Device; Fracture; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SINGLE STAGE VENOUS CANNULA, IT WAS REPORTED THAT ABOUT TEN MINUTES AFTER THE START OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), A FRACTURE OF THE CANNULA APPEARED WHILE TYING THE WIRE (PREMICRON 1) TO ATTACH THE DEVICE TO THE SKIN. THE WIRE CUT THE CANNULA IN TWO, RESULTING IN MASSIVE AIR ENTRY INTO THE ECMO CIRCUIT, SINCE THIS CANNULA IS POSITIONED ON THE SUCTION (DRAINAGE) PART OF THE CIRCUIT. THE CUSTOMER IMMEDIATELY STOPPED ECMO AND CLAMPED THE ARTERIAL LINE. NO AIR PASSAGE WAS OBSERVED IN THE ARTERIAL PART OF THE CIRCUIT NEITHER UPSTREAM OF THE CLAMP, NOR DOWNSTREAM, SO NO PRIOR GAS EMBOLISM BUT IT WAS NECESSARY TO REDO THE CANNULATION AND CHANGE THE ECMO CIRCUIT WHICH RESULTED IN A LOW-FLOW OF 45-50 MEAN ARTERIAL PRESSURE (MAP) FOR 15 MINUTES AND A HEMODILUTION TO 7.5G FOLLOWED BY A TRANSFUSION OF PSL (PRODUIT SANGUIN LABILE - BLOOD PRODUCT) (2/2/1 MINIMUM). THE BLOOD BALANCE WAS NORMALIZED THAT DAY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypovolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093207 ↗

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;