J-VAC 2162Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031003316), received between Sep 5, 2018 and Jun 19, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND A RESERVOIR WAS USED. THE RESERVOIR DID NOT MAKE THE VACUUM AFTER MANIPULATING THE BREAK. THEY INDICATED TO HOLD THE DRAIN WAS ESCAPING THE VACUUM. ACCORDING TO THE REPORT, AFTER CHANGING THE RESERVOIR, THE VACUUM WAS RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565262 ↗
• MalfunctionJan 14, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A RESERVOIR WAS USED. DURING THE PROCEDURE, WHEN INSTALLING THE DRAIN IT WAS NOTICED THAT IT WAS NOT PERFORMING SUCTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069703 ↗
• MalfunctionJan 13, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A RESERVOIR WAS USED. DURING THE PROCEDURE, ONE OF THE RESERVOIRS BECAME NON-FUNCTIONAL AND THEY COULD NOT USE IT TO LEAVE THE DRAINAGE SYSTEM FOR THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056323 ↗
• MalfunctionSep 23, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. THE DRAIN SPRING DID NOT WORK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123118 ↗
• MalfunctionJan 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. THE SCRUB SISTER ADVISED THAT THEY WERE HAVING ISSUES WITH THE RESERVOIR, IT WOULD NOT ALLOW THEM TO ACTIVATE THE SUCTION. WHEN TRYING TO TAKE MEASUREMENTS AND WAS SUCKING IN AIR AFTER DRAINING THE BAG THE FIRST TIME. A NEW RESERVOIR HAD TO BE OPENED AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21142736 ↗
• MalfunctionJan 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. THE SCRUB SISTER ADVISED THAT THEY WERE HAVING ISSUES WITH THE RESERVOIR, IT WOULD NOT ALLOW THEM TO ACTIVATE THE SUCTION. WHEN TRYING TO TAKE MEASUREMENTS AND WAS SUCKING IN AIR AFTER DRAINING THE BAG THE FIRST TIME. A NEW RESERVOIR HAD TO BE OPENED AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21142693 ↗
• MalfunctionDec 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN HYSTERECTOMY ON (B)(6)2024 AND A RESERVOIR WAS USED. RESERVOIR DID NOT "DRAIN", FILLED WITH AIR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20896568 ↗
• MalfunctionJul 25, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2024 AND A RESERVOIR WAS USED. IN SEVERAL TANKS DID NOT WORK THE VACUUM SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826266 ↗
• MalfunctionJul 24, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNONWN PROCEDURE ON AN UNKNOWN DATE IN JUN-2024 AND A RESERVOIR WAS USED. IN SEVERAL TANKS DID NOT WORK THE VACUUM SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820312 ↗
• MalfunctionMay 23, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A RESERVOIR WAS USED. THE SUCTION RESERVOIR DEVICE HAS JAMMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382136 ↗
• MalfunctionJan 31, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND RESERVOIR WAS USED. WE HAVE HAD AN ISSUE WITH RESERVOIR. WE'VE RECENTLY USED AND DO NOT HOLD THE SPRING SUCTION AFTER WE'VE PUT THEM ON PATIENT. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270828 ↗
• MalfunctionJan 30, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND RESERVOIR WAS USED. WE HAVE HAD AN ISSUE WITH RESERVOIR. WE'VE RECENTLY USED AND DO NOT HOLD THE SPRING SUCTION AFTER WE'VE PUT THEM ON PATIENT. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16265491 ↗
• MalfunctionJun 8, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND A RESERVOIR WAS USED. THE RESERVOIR IS ACTIVATED, LOSING THE VACUUM COMPLETELY. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14638261 ↗
• MalfunctionJan 6, 2020Suction Problem; Suction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND A RESERVOIR WAS USED, AT THE TIME OF CONNECTING THE RESERVOIR IT COULD NOT BE ACTIVATED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553229 ↗
• MalfunctionJan 8, 2019Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS CONNECTED TO A DRAIN. IT WAS REPORTED THAT THERE WAS INADEQUATE VACUUM MECHANISM AND POOR INTERNAL HYGIENE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8226486 ↗
• MalfunctionSep 5, 2018Suction Problem; Suction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR RESECTION OF ADIPOSE TISSUE IN THE THIGH, BUTTOCKS AND ARMS ON (B)(6) 2018 AND A RESERVOIR WAS CONNECTED TO A DRAIN. DURING THE PROCEDURE, THE RESERVOIR DID NOT HAVE VACUUM AND HAD TO BE REPLACED BY ANOTHER. THE SURGERY WAS NOT PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7845331 ↗