J-VAC 2163Recalls & reported problems
Ethicon Inc. · Suction Reservoir 300 mL with "Y" Connector and Anti-Reflux Valve · Class 2
Quick summary
This Ethicon J-VAC suction reservoir collects fluid after surgery using vacuum suction. Reports mostly describe reservoirs that would not activate vacuum, often because the internal spring did not work, plus bags that broke or leaked and had to be replaced. There are 25 reports that name its identifier, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031003323), received between Jun 2, 2020 and Jun 9, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (21 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.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow21
- Leak/Splash3
- Suction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Leak/Splash
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. IT SHOWED A BREAK IN THE COLLECTOR BAG, NEEDING TO BE REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446192 ↗MalfunctionJun 9, 2026Leak/Splash
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. IT SHOWED A BREAK IN THE COLLECTOR BAG, NEEDING TO BE REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446116 ↗MalfunctionJun 20, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A RESERVOIR WAS USED. THE DR. VERBALIZED THE RESERVOIR IS FAULTY. THERE WAS NO VACUUM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22298989 ↗MalfunctionMay 7, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A RESERVOIR WAS USED. PRODUCT DID NOT BREAK THE BOTTOM TO ACTIVATE THE VACUUM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21976128 ↗MalfunctionFeb 18, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A RESERVOIR WAS USED. WHEN ASSEMBLED ON THE PATIENT, THE VACUUM WAS NOT TRIGGERED AND THE MATERIAL NEEDED TO BE REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21402422 ↗MalfunctionDec 3, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND A RESERVOIR WAS USED. THE NURSING TEAM OPENED THE PACKAGING AND AT THE TIME OF STARTING ITS USE, THEY IDENTIFIED THAT THE SPRING TO MAKE THE "CLICK" AND START THE VACUUM-SUCTION WAS NOT WORKING. PRODUCT DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20835444 ↗MalfunctionMay 5, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. RECORD WITH PROBLEM IN THE VACUUM OPERATION, THE INTERNAL SPRING DOES NOT WORK. I IDENTIFY A SPRING THAT BROKE WHEN THE PATIENT'S DEBT WAS DISCARDED. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16875086 ↗MalfunctionMay 3, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. RECORD WITH PROBLEM IN THE VACUUM OPERATION, THE INTERNAL SPRING DOES NOT WORK. I IDENTIFY A SPRING THAT BROKE WHEN THE PATIENT'S DEBT WAS DISCARDED. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16865220 ↗MalfunctionMay 3, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. RECORD WITH PROBLEM IN THE VACUUM OPERATION, THE INTERNAL SPRING DOES NOT WORK. I IDENTIFY A SPRING THAT BROKE WHEN THE PATIENT'S DEBT WAS DISCARDED. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16865210 ↗MalfunctionMay 3, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. RECORD WITH PROBLEM IN THE VACUUM OPERATION, THE INTERNAL SPRING DOES NOT WORK. I IDENTIFY A SPRING THAT BROKE WHEN THE PATIENT'S DEBT WAS DISCARDED. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16865208 ↗MalfunctionMay 3, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. RECORD WITH PROBLEM IN THE VACUUM OPERATION, THE INTERNAL SPRING DOES NOT WORK. I IDENTIFY A SPRING THAT BROKE WHEN THE PATIENT'S DEBT WAS DISCARDED. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16865206 ↗MalfunctionMay 3, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. RECORD WITH PROBLEM IN THE VACUUM OPERATION, THE INTERNAL SPRING DOES NOT WORK. I IDENTIFY A SPRING THAT BROKE WHEN THE PATIENT'S DEBT WAS DISCARDED. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16865205 ↗MalfunctionMay 3, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. RECORD WITH PROBLEM IN THE VACUUM OPERATION, THE INTERNAL SPRING DOES NOT WORK. I IDENTIFY A SPRING THAT BROKE WHEN THE PATIENT'S DEBT WAS DISCARDED. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16865113 ↗MalfunctionMay 3, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. RECORD WITH PROBLEM IN THE VACUUM OPERATION, THE INTERNAL SPRING DOES NOT WORK. I IDENTIFY A SPRING THAT BROKE WHEN THE PATIENT'S DEBT WAS DISCARDED. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16865110 ↗MalfunctionJul 25, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE (B)(6) 2022 . AND A RESERVOIR WAS USED. DURING SURGERY, THE RESERVOIR HAS STOPPED SUCKING. NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15098463 ↗MalfunctionMar 23, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN ABDOMINOPLASTY ON (B)(6) 2022 AND A RESERVOIR WAS USED. THE PIECE OF METAL THAT IS INSIDE THE RESERVOIR BROKE, STOPPING THE SUCTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13860296 ↗MalfunctionFeb 23, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. AFTER PROCEDURE, THE RESERVOIR FAILED TO PERFORM TO SPECIFICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13588966 ↗MalfunctionNov 16, 2021Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT A MASTECTOMY ON (B)(6) 2021 AND A RESERVOIR WAS USED. DURING SURGERY, WHEN THE RESERVOIR WAS USED IT DID NOT COMPRESS. WHEN THEY SQUEEZED THE WHITE PLATES TOGETHER, THE CENTRAL WINDOW DID NOT CLICK INTO PLACE, UNABLE TO CREATE A VACUUM. THEY HAVE USED FOR THIS PATIENT ANOTHER RESERVOIR TO MONITOR THE THIS ONE TO MAKE SURE THAT IT IS NOT FAULTY AND DID NOT WORK PROPERLY. SURGERY DELAYED ABOUT 5 - 10 MINUTES, ACTION TAKEN WHEN EVENT OCCURRED, TOOK A THIRD ONE THAT WORKED. PROCEDURE SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12821268 ↗MalfunctionNov 16, 2021Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT A MASTECTOMY ON (B)(6) 2021 AND A RESERVOIR WAS USED. DURING SURGERY, WHEN THE RESERVOIR WAS USED IT DID NOT COMPRESS. WHEN THEY SQUEEZED THE WHITE PLATES TOGETHER, THE CENTRAL WINDOW DID NOT CLICK INTO PLACE, UNABLE TO CREATE A VACUUM. THEY HAVE USED FOR THIS PATIENT ANOTHER RESERVOIR TO MONITOR THE THIS ONE TO MAKE SURE THAT IT IS NOT FAULTY AND DID NOT WORK PROPERLY. SURGERY DELAYED ABOUT 5 - 10 MINUTES, ACTION TAKEN WHEN EVENT OCCURRED, TOOK A THIRD ONE THAT WORKED. PROCEDURE SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12821247 ↗MalfunctionNov 2, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND RESERVOIR WAS USED. DURING SURGERY, RESERVOIR WAS LEAKING. ANOTHER PRODUCT THAT WAS IN STOCK WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12741015 ↗MalfunctionDec 2, 2020Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT A MYOCARDIAL REVASCULARIZATION ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. THE RESERVOIR FUNCTIONED APPROPRIATELY INITIALLY. TWO TO THREE DAYS AFTER THE PROCEDURE THERE WAS AN ISSUE WITH ABSENCE OF THE VACUUM AND FAILURE IN THE DRAINAGE, DUE TO DISPLACEMENT OF THE SECRETION OUTLET TO THE RESERVOIR. THE RESERVOIR, PRESENTS A DISCONNECTION OF BOTH THE DRAINAGE AND DISPOSAL CHANNEL, THERE WAS NO COMPLICATION TO THE PATIENT. THE SAME RESERVOIR WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10932528 ↗MalfunctionDec 2, 2020Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT A MYOCARDIAL REVASCULARIZATION ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. THE RESERVOIR FUNCTIONED APPROPRIATELY INITIALLY. TWO TO THREE DAYS AFTER THE PROCEDURE THERE WAS AN ISSUE WITH ABSENCE OF THE VACUUM AND FAILURE IN THE DRAINAGE, DUE TO DISPLACEMENT OF THE SECRETION OUTLET TO THE RESERVOIR. THE RESERVOIR, PRESENTS A DISCONNECTION OF BOTH THE DRAINAGE AND DISPOSAL CHANNEL, THERE WAS NO COMPLICATION TO THE PATIENT. THE SAME RESERVOIR WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10932513 ↗MalfunctionDec 2, 2020Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT A MYOCARDIAL REVASCULARIZATION ON (B)(6) 2020 AND A RESERVOIR WAS USED. THE RESERVOIR FUCTIONED APPROPRIATELY INITIALLY. TWO TO THREE DAYS AFTER THE PROCEDURE THERE WAS AN ISSUE WITH ABSENCE OF THE VACUUM AND FAILURE IN THE DRAINAGE, DUE TO DISPLACEMENT OF THE SECRETION OUTLET TO THE RESERVOIR. THE RESERVOIR, PRESENTS A DISCONNECTION OF BOTH THE DRAINAGE AND DISPOSAL CHANNEL, THERE WAS NO COMPLICATION TO THE PATIENT. THE SAME RESERVOIR WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10932471 ↗MalfunctionDec 2, 2020Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A PATIENT UNDERWENT A MYOCARDIAL REVASCULARIZATION ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. THE RESERVOIR FUNCTIONED APPROPRIATELY INITIALLY. TWO TO THREE DAYS AFTER THE PROCEDURE THERE WAS AN ISSUE WITH ABSENCE OF THE VACUUM AND FAILURE IN THE DRAINAGE, DUE TO DISPLACEMENT OF THE SECRETION OUTLET TO THE RESERVOIR. THE RESERVOIR, PRESENTS A DISCONNECTION OF BOTH THE DRAINAGE AND DISPOSAL CHANNEL, THERE WAS NO COMPLICATION TO THE PATIENT. THE SAME RESERVOIR WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10932465 ↗MalfunctionJun 2, 2020Suction Problem; Suction Problem
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE A RESERVOIR WAS USED. AFTER SURGERY, THE PATIENT BEING IN THE ROOM, IT COULD NOT BE DRAINED SINCE THE EQUIPMENT WAS OBSTRUCTED, THE CHANGE WAS REQUESTED TO THE PHARMACY SUPERVISOR, WHO CHANGED IT AND GOT IT WORKING CORRECTLY. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10112990 ↗
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- Medline Industries, Inc. OR929KMedline Industries, Inc. · CATHETER AND TIP, SUCTION1 recall0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.