Custom Perfusion System CB4W67R15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169602762), received between Jan 4, 2017 and Jan 4, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Misassembled” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Feb 4, 2016Terminated

   Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.

   Z-1023-2016 · Root cause: Component design/selection · Recall details · FDA record ↗

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.

• MalfunctionJan 4, 2017Misassembled; Misassembled

  MEDTRONIC RECEIVED INFORMATION THAT AFTER INITIATING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT USING A MEDTRONIC TUBING PACK, THE CUSTOMER OBSERVED VERY LOW PATIENT BLOOD PRESSURE. AFTER APPROXIMATELY SEVEN MINUTES, THE CUSTOMER REALIZED THE RED AND BLUE LABELS ON THE TUBING OUTSIDE OF THE STERILE FIELD, DID NOT COINCIDE WITH THE RED BLUE LABELS ON THE INSIDE OF THE STERILE FIELD THAT WERE CONNECTED TO THE ARTERIAL AND VENOUS CANNULA. THE LINES WERE CLAMPED, TUBING CUT, AND CIRCUIT RE-CONNECTED THE CORRECT WAY. PATIENT BLOOD PRESSURE RETURNED TO NORMAL AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT IS NOT EXPECTED TO RETURN TO MEDTRONIC FOR ANALYSIS. DURING PRIMING OF THIS CIRCUIT, THE CUSTOMER OBSERVED A LEAK FROM THE 3/8 INCH CONNECTOR WITH BLUE TAPE. THE CUSTOMER CUT THE PIECE TO REPLACE IT WITH ANOTHER CONNECTOR. WHILE THE LEAKING CONNECTOR HAD BLUE TAPE PRESENT, THE REPLACEMENT CONNECTOR DID NOT. AFTER THE CONNECTOR WAS REPLACED, PRIMING WAS COMPLETED AND ECMO INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6221811 ↗