J-VACRecalls & reported problems across all models

We found 5 models of J-VAC by Ethicon Inc. in the FDA's device registry (GUDID). Together they are named in 215 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2018 and Sep 1, 2026 — classified as 3 injuries, 212 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (110 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported J-VAC problems

J-VAC models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• J-VAC 2160

  CATHETER AND TIP, SUCTION
  152 reports
• J-VAC 2163

  CATHETER AND TIP, SUCTION
  25 reports
• J-VAC 2161

  CATHETER AND TIP, SUCTION
  19 reports
• J-VAC 2162

  CATHETER AND TIP, SUCTION
  16 reports
• J-VAC BCC1

  CATHETER, IRRIGATION
  3 reports

Recent J-VAC adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗

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