J-VAC BCC1Recalls & reported problems
Ethicon Inc. · BLAKE CARDIO CONNECTOR 1:1 · Class 1 · Implant
All models of J-VAC (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031023314), received between May 31, 2023 and Jul 31, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED A PATIENT AN UNKNOWN CARDIOVASCULAR SURGERY ON AND UNKNOWN DATE AND A RESERVOIR WAS USED. THERE WAS A SOUND LEAKAGE FROM THE CONNECTION PART WHEN CONNECTED TO THE CARDIO CONNECTOR. USE WAS STOPPED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22675815 ↗MalfunctionJun 10, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED A PATIENT UNDERWENT CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND A CARDIO CONNECTOR WAS USED. IT HAD BEEN MANAGED WASTE FLUID IN THE ICU, THE DRAIN BECAUSE OF THE AIR LEAK, IT WAS FOUND THAT A SMALL HOLE. IT HAD BEEN A POSSIBILITY OF LEAK, SO REPLACED THE NEW PRODUCT. IT WAS NOT HEALTH INJURY. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEE REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19498418 ↗MalfunctionMay 31, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A CARDIAC DRAIN CONNECTOR WAS USED. DURING PROCEDURE, RED FIBROUS FOREIGN MATTER WAS FOUND IN THE STERILE PACKAGE, IT WAS NOT USED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17034605 ↗
Other CATHETER, IRRIGATION devices
- Navarre Opti-Drain NOD8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION901 reports
- Navarre NNU8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION736 reports
- BLAKE 2227Ethicon Inc. · CATHETER, IRRIGATION331 reports
- Navarre NNU6LPTBard Access Systems, Inc. · CATHETER, IRRIGATION211 reports
- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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