Cardiovascular Procedure Kit 76810Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00699753509054), received between Dec 18, 2018 and Jan 9, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2019Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE LEUKOCYTE FILTER BURST WITHIN MINUTES OF THE INITIATING ITS USE. THE PERFUSIONIST (USER OF THE DEVICE) WAS EXPOSED TO INFECTIOUS BLOOD WHEN IT GOT INTO THE USERS' RIGHT EYE. THE USER WAS WEARING GLOVES, NO PROTECTIVE GOWN OR EYE PROTECTION WAS UTILIZED. THE USER WENT TO THE EMERGENCY ROOM AND WAS STARTED ON ANTIVIRAL MEDICATION.

  Patient problems: Exposure to Body Fluids; Hepatitis

  MAUDE report 8232533 ↗
• MalfunctionJan 9, 2019Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE LEUKOCYTE FILTER BURST WITHIN MINUTES OF THE INITIATING ITS USE. THE DEVICE WAS CLAMPED OUT AND THE RECIRCULATION LINE WAS UTILIZED. THIS RESULTED APPROXIMATELY 100 ML BLOOD LOSS, THERE WAS NO DELAY, AND THE SURGICAL OUTCOME WAS SUCCESSFUL. THERE WAS NO MAJOR PATIENT IMPACT .

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 8231996 ↗
• MalfunctionJan 4, 2019Disconnection; Disconnection

  THE CUSTOMER REPORTED THAT THE CUSTOMER CONNECTION OF THE RECIRCULATION LINE TO THE OXYGENATOR, CARDIOPLEGIA PORT DISCONNECTED, APPROXIMATELY 40 MINUTES INTO THE SURGERY. THIS RESULTED IN 150-200 ML BLOOD LOSS. THE LINE WAS RECONNECTED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE CUSTOMER INDICATED THE PATIENT WAS FINE.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 8218241 ↗
• MalfunctionDec 18, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEUKOCYTE FILTER BURST WHILE THE PULMONOPLEGIA WITHIN 2 MINUTES OF INITIATION. THE DEVICE WAS REPLACED WITH A STRAIGHT CONNECTOR. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, AND APPROXIMATELY 200 ML BLOOD LOSS. NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 8176420 ↗