BLAKE BCC2Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031023321), received between Jun 30, 2020 and Sep 24, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885359 ↗
• MalfunctionApr 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A CARDIO CONNECTOR WAS USED. THE NURSE LOOKED INSIDE THE PACKAGE BEFORE USE, IT WAS FOUND THAT THERE WAS A SMALL BROWN SUBSTANCE IN IT, SO THE PRODUCT COULD NOT BE USED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846970 ↗
• MalfunctionApr 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A CARDIO CONNECTOR WAS USED. THE NURSE LOOKED INSIDE THE PACKAGE BEFORE USE, IT WAS FOUND THAT THERE WAS A SMALL BROWN SUBSTANCE IN IT, SO THE PRODUCT COULD NOT BE USED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846967 ↗
• MalfunctionApr 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A CARDIO CONNECTOR WAS USED. THE NURSE LOOKED INSIDE THE PACKAGE BEFORE USE, IT WAS FOUND THAT THERE WAS A SMALL BROWN SUBSTANCE IN IT, SO THE PRODUCT COULD NOT BE USED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846965 ↗
• MalfunctionApr 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A CARDIO CONNECTOR WAS USED. THE NURSE LOOKED INSIDE THE PACKAGE BEFORE USE, IT WAS FOUND THAT THERE WAS A SMALL BROWN SUBSTANCE IN IT, SO THE PRODUCT COULD NOT BE USED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846963 ↗
• MalfunctionFeb 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A CARDIO CONNECTOR WAS USED. WHEN THE PATIENT RETURNED TO THE WARD, IT WAS CONFIRMED THAT AIR LEAKAGE OCCURRED. A NURSE CHECKED THE PRODUCT AND THE AIR LEAKAGE WAS COMING FROM THE CARDIO CONNECTOR, AND REPLACING THE CARDIO CONNECTOR FIXED THE AIR LEAKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699708 ↗
• MalfunctionJun 10, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT ON (B)(6) 2022 AND A CONNECTOR WAS USED. AFTER THE SURGERY, IN THE ICU, THE SURGEON CONFIRMED THAT AIR LEAKAGE OCCURRED AT THE CONNECTION PART. THE CONNECTION BETWEEN THE CONNECTOR AND THE DRAIN WAS HELD TOGETHER BY SOMETHING LIKE A ZIP TIE. A DRAIN WAS FOUND BROKEN IN THE AREA IN CONTACT WITH THE TIP OF THE CONNECTOR. THE DOCTOR COMMENTED THAT A METAL PART OF A MILKING ROLLER WAS THE CAUSE OF THE BREAKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14656254 ↗
• MalfunctionAug 24, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A CARDIO CONNECTOR WAS USED. IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE LIKE A HAIR IN THE STERILE PACKAGE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12357925 ↗
• MalfunctionJun 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND TOPICAL SKIN ADHESIVE WAS USED. BEFORE OPENING THE STERILE PACKAGE, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE LIKE A HAIR IN THE STERILE PACKAGE. THE PRODUCT WAS NOT USED AND ANOTHER PACKAGE WAS OPENED. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213435 ↗