J-VAC 2160Recalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10705031003293), received between Jun 13, 2018 and Sep 1, 2026 — classified as 3 injuries, 149 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (66 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 25 most recent of 152 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Material Integrity Problem

  It was reported that a patient underwent an unknown procedure on (b)(6)2026 and a reservoir was used. Prior to use on the patient, when the drainage was attached, it was broken at the marked points. There were no adverse patient consequences reported. Upon evaluation of returned device, significant cut marks visible on the cut-off surface of the bulb port.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50545266 ↗
• MalfunctionSep 1, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50545264 ↗
• MalfunctionAug 10, 2026Material Integrity Problem

  It was reported a Patient underwent a hysterectomy + resection of an abdominal wall tumor on (b)(6)-2026 and a bulb reservoir was used. When the drain was introduced into the reservoir, it was noticed that the reservoir connection was broken.Additional information has been requested.Upon receipt and analysis, port is broken in unusual form which shows that twisting force.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201218 ↗
• MalfunctionJun 25, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND RESERVOIR WAS USED. THERE WAS A DEFECT IN THE CONNECTION OF THE RESERVOIR, THE RESERVOIR USED CORRESPONDED TO THE ADAPTER OF THE DRAIN, THE PROBLEM WAS VERIFIED BEFORE THE ACTIVATION OF THE RESERVOIR, THERE WAS NO LEAK AND THE PROCEDURE WAS COMPLETED WITH THE SAME PRODUCT FROM THE SAME LABORATORY. THE PRODUCT BEFORE USE, WAS STORED ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RECEIPT AND ANALYSIS, SIGNIFICANT CUT MARKS WERE VISIBLE. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619166 ↗
• MalfunctionJun 8, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2026 AND A BULB RESERVOIR WAS USED. THE SUCTION RESERVOIR DID NOT HAVE THE LINE CONNECTOR THAT ALLOWS A SECURE ATTACHMENT OF THE DRAINAGE TUBE TO THE RESERVOIR BULB, SO IT WAS IMPOSSIBLE FOR THE CLINICIAN TO INSTALL THE RESERVOIR BULB SAFELY AND SECURELY ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435570 ↗
• MalfunctionApr 29, 2026Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT A RHYTIDOPLASTY AND RHINOPLASTY ON (B)(6) 2026 AND A RESERVOIR WAS USED. UPON PLACEMENT OF THE DRAIN, IT WAS DETECTED THAT THE NEGATIVE PRESSURE WAS NOT FUNCTIONING, AND IT WAS NECESSARY TO REQUEST REPLACEMENT WITH ANOTHER RESERVOIR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031852 ↗
• MalfunctionApr 21, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE A RESERVOIR WAS USED. THE CONNECTION PART BETWEEN RESERVOIR AND ADAPTER WAS BROKEN. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION, CONNECTION PORT (STUCK INSIDE THE ADAPTER) ALSO HAD VISIBLE CUT MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941917 ↗
• MalfunctionApr 21, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND A RESERVOIR WAS USED. DEFECTIVE MATERIAL ON THE TOP PRIOR TO SURGERY. UPON RECEIPT AND ANALYSIS OF THE RESERVOIR, THE CONNECTION PORT OF THE BULB WAS SEPARATED FROM BULB CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24936924 ↗
• MalfunctionMar 3, 2026Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A RESERVOIR WAS USED. IT IS PASSED TO SURGICAL TABLE RESERVOIR OF 100 WHEN THE RESIDENT OF GENERAL SURGERY CONNECTS TO DRAIN, INFORMS THAT THE TIE IS VERY SMALL AND IS LOOSE, IT IS NOT EMPTY, YOU CAN NOT CONNECT TO RESERVOIR, ANOTHER ONE IS REQUESTED AND THIS ONE IF IT CONNECTS. THE SAMPLE IS AVAILABLE FOR ANALYSIS. UPON RECEIPT AND EVALUATION OF RESERVOIR, FOUND THAT THERE WERE SIGNIFICANT CUT MARKS VISIBLE ON THE CUT-OFF SURFACE OF THE BULB PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497050 ↗
• MalfunctionDec 8, 2025Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. DURING THE PROCEDURE, THE DRAINAGE WAS LEAKED, AND THE RESERVOIR COULD NOT BE USED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742530 ↗
• MalfunctionJul 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN PORT WAS BROKEN WHEN THE PACKAGE WAS OPENED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS THE PORT WAS PARTIALLY SEPARATED AND CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554181 ↗
• MalfunctionJul 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A BULB RESERVOIR WAS USED. THE CONNECTION PART OF THE RESERVOIR WAS BROKEN. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS OBSERVED VISIBLE CUT MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470950 ↗
• MalfunctionJun 19, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A BULB RESERVOIR WAS USED. DURING USE, WHEN FIDDLED THE CAP BEFORE USE, IT WAS BROKEN. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.UPON RECEIPT AND ANALYSIS IT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293648 ↗
• MalfunctionMay 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. WHEN TRYING TO CONNECT THE CONNECTOR AND THE BAG BEFORE USE WITH THE PATIENT, IT FELT LIKE THE CONNECTOR WAS BROKEN, SO THE USE WAS STOPPED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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 21994436 ↗
• MalfunctionApr 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A BULB RESERVOIR WAS USED. IT WAS BROKEN WHEN INSERTING TO THE CONNECTION PART. THERE WAS NO EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RECEIPT AND ANALYSIS, IT WAS NOTED THE CONNECTION PORT OF THE BULB WAS SEPARATED, AND THERE WAS A CUT MARK VISIBLE ON THE REMAINING PORTION OF THE BULB PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933769 ↗
• MalfunctionApr 29, 2025Leak/Splash; Leak/Splash

  AT THE END OF THE SURGERY, A 100 ML RESERVOIR WAS INSERTED FOR THE DRAIN, AND IT WAS FOUND THAT ONE OF ITS TIPS FOR THE DRAIN CONNECTION WAS BROKEN. AN ATTEMPT WAS MADE TO MAKE AN ADDITIONAL CONNECTION, BUT A LEAK WAS NOTICED, SO ANOTHER 100 ML RESERVOIR WAS INSERTED. THE SAMPLE WAS AVAILABLE FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930269 ↗
• MalfunctionApr 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A RESERVOIR WAS USED. AT THE MOMENT OF CONNECTING THE DRAIN TO THE RESERVOIR THE BAG CONNECTOR AT THE TOP OF THE BAG IS BROKEN. THE TOP OF THE BAG. REPLACEMENT IS REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RECEIPT AND ANALYSIS OF SAMPLE THE CONNECTION PORT OF THE BULB WAS SEPARATED FROM THE LAST STEP, AND THERE WERE SIGNIFICANT CUT MARKS VISIBLE ON THE SEPARATION SURFACE OF THE BULB PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898365 ↗
• MalfunctionMar 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BULB RESERVOIR WAS USED. SUCTION COULD NOT BE DONE, PERHAPS DUE TO AN AIR LEAK. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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 21667825 ↗
• MalfunctionMar 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A RESERVOIR WAS USED. THE RESERVOIR IMMEDIATELY HAD BEEN SWELLED. 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 21545776 ↗
• 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. DEVICE DOES NOT PERFORM SUCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403234 ↗
• MalfunctionFeb 5, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A BULB RESERVOIR WAS USED. THE EQUIPMENT IS OPENED IN THE SURGICAL FIELD AND IT IS OBSERVED THAT THE RESERVOIR IS LEAKING. THIS IS USED UNTIL THE LEAK IS NOTED, SO IT IS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315241 ↗
• MalfunctionFeb 5, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A BULB RESERVOIR WAS USED. DELIVERED TO SUPPLIER, MATERIAL LEAKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315167 ↗
• MalfunctionFeb 4, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND A BULB RESERVOIR WAS USED. ITEM CANNOT PREFORM SUCTION AFTER INSTALLATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303440 ↗
• MalfunctionFeb 4, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A BULB RESERVOIR WAS USED. ITEM CANNOT PREFORM SUCTION AFTER INSTALLATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303439 ↗
• MalfunctionFeb 4, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A BULB RESERVOIR WAS USED. ITEM CANNOT PREFORM SUCTION AFTER INSTALLATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303437 ↗