J-VAC 2161Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031003309), received between Mar 28, 2019 and Mar 21, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT A LAPAROSCOPIC APPENDIX PROCEDURE ON AN UNKNOWN DATE IN 2025 AND A RESERVOIR WAS USED. WHEN HCP TRIED TO OPEN THE RESERVOIR DURING CASE, THEY REALIZED THE DEVICE WAS HAVING SUCTION FAULTY ISSUE. THE SURGERY WAS CARRIED ON BY USING ANOTHER RESERVOIR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665593 ↗
• MalfunctionOct 31, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. POST-OP THE BAG STARTED LEAKING FROM THE SEAM FIVE DAYS AFTER ACTIVATION. NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041529 ↗
• MalfunctionFeb 8, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDEWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND A RESERVOIR WAS USED. THERE WAS NO SUCTION ON THE RESERVOIR. THEY HAD TO OPEN A SECOND RESERVOIR. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328148 ↗
• MalfunctionAug 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SENOLOGY SURGERY ON AN UNKNOWN DATE IN 2022 AND A RESERVOIR WAS USED. THE PRODUCT DID NOT MAINTAIN A VACUUM CONDITION. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225497 ↗
• MalfunctionAug 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SENOLOGY SURGERY ON AN UNKNOWN DATE IN 2022 AND A RESERVOIR WAS USED. THE PRODUCT DID NOT MAINTAIN A VACUUM CONDITION. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225478 ↗
• MalfunctionAug 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SENOLOGY SURGERY ON AN UNKNOWN DATE IN 2022 AND A RESERVOIR WAS USED. THE PRODUCT DID NOT MAINTAIN A VACUUM CONDITION. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225462 ↗
• MalfunctionAug 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SENOLOGY SURGERY ON AN UNKNOWN DATE IN 2022 AND A RESERVOIR WAS USED. THE PRODUCT DID NOT MAINTAIN A VACUUM CONDITION. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225438 ↗
• MalfunctionAug 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SENOLOGY SURGERY ON AN UNKNOWN DATE IN 2022 AND A RESERVOIR WAS USED. THE PRODUCT DID NOT MAINTAIN A VACUUM CONDITION. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225435 ↗
• MalfunctionAug 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SENOLOGY SURGERY ON AN UNKNOWN DATE IN 2022 AND A RESERVOIR WAS USED. THE PRODUCT DID NOT MAINTAIN A VACUUM CONDITION. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225428 ↗
• MalfunctionAug 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SENOLOGY SURGERY ON AN UNKNOWN DATE IN 2022 AND A RESERVOIR WAS USED. THE PRODUCT DID NOT MAINTAIN A VACUUM CONDITION. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225424 ↗
• MalfunctionAug 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SENOLOGY SURGERY ON AN UNKNOWN DATE IN 2022 AND A RESERVOIR WAS USED. THE PRODUCT DID NOT MAINTAIN A VACUUM CONDITION. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225422 ↗
• MalfunctionAug 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SENOLOGY SURGERY ON AN UNKNOWN DATE IN 2022 AND A RESERVOIR WAS USED. THE PRODUCT DID NOT MAINTAIN A VACUUM CONDITION. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225420 ↗
• MalfunctionAug 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SENOLOGY SURGERY ON AN UNKNOWN DATE IN 2022 AND A RESERVOIR WAS USED. THE PRODUCT DID NOT MAINTAIN A VACUUM CONDITION. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225393 ↗
• MalfunctionMar 30, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. RESERVOIR WAS NOT SUCTIONING PROPERLY. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13953262 ↗
• MalfunctionFeb 16, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND A RESERVOIR WAS USED. DURING THE PROCEDURE, THERE WAS A VACUUM PROBLEM DURING SUCTION WITH RESERVOIR AND SUCTION WAS UNSUCCESSFUL. ITEM WAS DISCARDED AS IT IS BLOOD STAINED. ANOTHER RESERVOIR WAS USED. PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334382 ↗
• MalfunctionMay 28, 2020Suction Problem; Suction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND A RESERVOIR WAS USED. DURING SURGERY, THERE WAS NO VACUUM/ SUCTION IN THE RESERVOIR. A NEW RESERVOIR WAS OPENED AND USED. WAS SURGERY DELAYED 10 MINUTES. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WERE NOT REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 10095764 ↗
• MalfunctionMay 28, 2020Suction Problem; Suction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND A RESERVOIR WAS USED. DURING SURGERY, THERE WAS NO VACUUM/ SUCTION IN THE RESERVOIR. A NEW RESERVOIR WAS OPENED AND USED. WAS SURGERY DELAYED 10 MINUTES. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WERE NOT REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 10095762 ↗
• MalfunctionMay 28, 2020Suction Problem; Suction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND A RESERVOIR WAS USED. DURING SURGERY, THERE WAS NO VACUUM/ SUCTION IN THE RESERVOIR. A NEW RESERVOIR WAS OPENED AND USED. WAS SURGERY DELAYED 10 MINUTES. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WERE NOT REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 10095755 ↗
• MalfunctionMar 28, 2019Suction Problem; Suction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND A RESERVOIR WAS USED CONNECTED TO A DRAIN. SCRUB NURSE COULD NOT ACTIVATE THE RESERVOIR. IT WOULD NOT LOCK INTO PLACE. THE DEVICE JUST POPPED BACK OPEN, AND WAS UNUSABLE. WHEN A SECOND RESERVOIR WAS OPENED, IT WORKED PERFECTLY. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458977 ↗