Veriset HP0510ERecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 20884521082554), received between Apr 6, 2017 and Nov 14, 2024 — classified as 1 death, 8 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Degraded” (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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Loss of or Failure to Bond; Difficult or Delayed Positioning; Mechanics Altered; Loss of or Failure to Bond; Difficult or Delayed Positioning; Mechanics Altered

  ACCORDING TO THE REPORTER, IN A LUNG LOBECTOMY, WHILE IN THE PULMONARY VESSEL, THE SURGEON NOTED THAT THERE WAS NO HEAT GENERATED AFTER APPLYING THREE HEMOSTATIC PATCHES. THE PATCHES ALSO DID NOT ADHERE. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689238 ↗
• MalfunctionNov 14, 2024Loss of or Failure to Bond; Difficult or Delayed Positioning; Mechanics Altered; Loss of or Failure to Bond; Difficult or Delayed Positioning; Mechanics Altered

  ACCORDING TO THE REPORTER, IN A LUNG LOBECTOMY, WHILE IN THE PULMONARY VESSEL, THE SURGEON NOTED THAT THERE WAS NO HEAT GENERATED AFTER APPLYING THREE HEMOSTATIC PATCHES. THE PATCHES ALSO DID NOT ADHERE. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689161 ↗
• MalfunctionNov 14, 2024Loss of or Failure to Bond; Difficult or Delayed Positioning; Mechanics Altered; Loss of or Failure to Bond; Difficult or Delayed Positioning; Mechanics Altered

  ACCORDING TO THE REPORTER, IN A LUNG LOBECTOMY, WHILE IN THE PULMONARY VESSEL, THE SURGEON NOTED THAT THERE WAS NO HEAT GENERATED AFTER APPLYING THREE HEMOSTATIC PATCHES. THE PATCHES ALSO DID NOT ADHERE. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689160 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON POST OPERATIVE FEMORAL- POPLITEAL BYPASS, THE DEVICE WAS PLACED OVER THE ANASTOMOSIS OF THE VESSELS FOR HEMOSTASIS HOWEVER THERE WAS NO HEMOSTASIS, THE DEVICE HAD DETACHED FROM THE ISSUE. THE SITE HAD HEMORRHAGE AND LED TO REOPERATION FOR POST OPERATIVE BLEEDING. TWO SMALLER PATCHES WERE TAKEN WHICH LED TO HEMOSTASIS AND RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20242863 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC PARTIAL NEPHRECTOMY WHERE THE DEVICE WAS APPLIED TO THE BED WHERE TUMOR WAS, THE PATIENT CONTRACTED AN INFECTION. KLEBSIELLA PNEUMONIAE AND ENTEROBACTER CLOACAE AND/OR ESCHERICHIA COLI APPEARED. PATIENT HOSPITALIZATION WAS EXTENDED AND THERE WAS A PROLONGED TREATMENT OF THE INFECTION. AN ADDITIONAL OPERATION WILL BE PERFORMED TO CORRECT THE ISSUE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9194821 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC PARTIAL NEPHRECTOMY WHERE DEVICE WAS APPLIED TO THE BED WHERE TUMOR WAS, THE PATIENT CONTRACTED AN INFECTION. KLEBSIELLA PNEUMONIAE AND ENTEROBACTER CLOACAE AND/OR ESCHERICHIA COLI APPEARED. PATIENT HOSPITALIZATION WAS EXTENDED AND THERE WAS A PROLONGED TREATMENT OF THE INFECTION. AN ADDITIONAL OPERATION WILL BE PERFORMED TO CORRECT THE ISSUE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9194771 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY A TOTAL THYROIDECTOMY PROCEDURE, THE PATIENT HAD A WOUND INFECTION AFTER USING THE PATCH. THE PATCH WAS OPENED FROM THE FOIL POUCH AND PLACED ON THE STERILE FIELD AN HOUR PRIOR TO BEING USED. PATIENT'S HOSPITALIZATION WAS EXTENDED AND WAS PROVIDED WITH IV ANTIBIOTICS.

  Patient problems: No Code Available; Post Operative Wound Infection

  MAUDE report 9182963 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A CESAREAN SECTION, THE PATIENT HAD SEROUS FLUID EXUDATION LEADING TO DISTENDED ABDOMEN, WHICH ALSO MIMICKED ACUTE ABDOMEN, ABDOMINAL PAIN WITH SOME GUARDING. IT WAS MANAGED CONSERVATIVELY.

  Patient problems: Abdominal Pain; No Code Available

  MAUDE report 8449735 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, THE PATIENT DEVELOPED A VAGINAL DISCHARGE AND PASSAGE OF MUCOUS SUBSTANCE IN THE VAGINA. THEY EXAMINED THE PATIENT AND REMOVED WHAT APPEARED TO THE DEVICE EXTRUDING THROUGH VAGINAL VAULT. THE DEVICE WAS THE ONLY FOREIGN BODY LEFT IN THE AREA.

  Patient problems: Abnormal Vaginal Discharge; Vaginal Mucosa Damage

  MAUDE report 8447790 ↗
• InjuryNov 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE'S PATCH TOOK OFF. THE DEVICE WAS USED IN THE CLOSING OF THE TUMOR RESECTION IN PARTIAL NEPHRECTOMY WITH TUMORECTOMY. THE PATIENT WAS REINTERVENTED 14 HOURS FROM THE ORIGINAL OPERATION. THE LAPAROSCOPIC PROCEDURE CONVERTED TO OPEN UNRELATED TO DEVICE PROBLEM. IT WAS DUE TO OBSERVATION OF PARALYTIC ILEUS IN THE SMALL INTESTINE, SPECIFICALLY IN THE JEJUNUM. THERE WAS BLOOD LOSS OF MORE THAN 500CC DUE TO THE PRODUCT PROBLEM AND REQUIRED BLOOD TRANSFUSION. THE POST-OPERATIVE BLEEDING WAS FROM THE SITE WHERE THE DEVICE WAS APPLIED.

  Patient problems: Blood Loss; Exsanguination; No Code Available

  MAUDE report 8084078 ↗
• MalfunctionAug 6, 2018Degraded; Material Integrity Problem; Degraded

  ACCORDING TO THE REPORTER, AT THE PREVIOUS DELIVERY OF THE DEVICE, TWO UNITS WERE OPENED AND BOTH PATCHES BASICALLY CRUMBLED IN THE HAND, FOR LAPAROSCOPIC USE AND THEY WERE ABSOLUTELY NOT USABLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7752163 ↗
• InjuryJul 30, 2018Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, ON HYSTERECTOMY, WHILE HEMOSTASIS, THE DEVICE CAUSED AN INFECTION THAT RESULTS IN VIOLENT PAINS AFTER 10 DAYS. THE EVENT LED TO EXTEND THE PATIENT¿S HOSPITALIZATION. A NEW OPERATION WAS PERFORMED TO TREAT THE INFECTION AND CORRECT THE ISSUE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7731375 ↗
• MalfunctionJul 13, 2018Break; Degraded; Degraded

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THEY OPENED THE DEVICE, IT WAS ALL DRY AND DESTROYED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7685192 ↗
• MalfunctionJun 11, 2018Degraded; Degraded

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY, THEY TRIED TO USE THE PATCH AND THE DOCTOR ADVISED IT WAS HARD AND THEY WERE UNABLE TO FORM IT TO THE BLEEDING SITE. THEY TRIED TO SOAK IT AND IT DID NOT STICK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7586242 ↗
• MalfunctionMay 1, 2018Degraded; Degraded

  ACCORDING TO THE REPORTER, PRIOR TO A LAP PROCEDURE, THE PATCH WAS HARD AND UNUSABLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7476016 ↗
• MalfunctionMar 7, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING AN OPEN LIVER PROCEDURE, PATCH WAS CRUMBLING IN THE TROCAR. THEY TOOK ON ANOTHER PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7322207 ↗
• DeathJan 18, 2018Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: OCCURRED POST-OPERATIVELY FOLLOWING A SLEEVE GASTRECTOMY. THE HEMOSTATIC COMPRESS WAS USED AT THE LEVEL OF THE SPLENIC PEDICLE OF THE PATIENT. AFTER SEVERAL DAYS, AN ABSCESS FORMED WITH AN UNDERLYING VASCULAR BREAK WITH INFLAMMATION. THE DEVICE WAS NOT ALLEGED TO BE THE SOURCE OF THE ABSCESS. THE PATIENT WAS TRANSFERRED IN ICU. THE PATIENT EXPIRED.

  Patient problems: Death

  MAUDE report 7203154 ↗
• MalfunctionJan 9, 2018Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVER RESECTION PROCEDURE, WHILE BEING APPLIED TO THE LIVER FOLLOWING RESECTION, THE DEVICE FELT DIFFERENT TO OTHER PIECES/WAS VERY STIFF AND WAS BREAKING EASILY. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7176682 ↗
• MalfunctionDec 5, 2017Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER: WHEN THE PACKAGING OF THE PRODUCT WAS OPENED, THE PATCHES WERE ALWAYS BROKEN IN SMALL PIECES WHEN TRYING TO ROLL IT. THE MATERIAL IS NOT FLEXIBLE ENOUGH. THE ISSUE OCCURRED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7085243 ↗
• MalfunctionNov 20, 2017Degraded; Degraded

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WAS CRACKED AND FELT CRISPY WHEN ATTEMPTING TO ROLL BEFORE INSERTING INTO THE TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7046444 ↗
• MalfunctionNov 8, 2017Degraded; Degraded

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CASE, EVERY TIME THE SURGEON PLACED THE DEVICE THROUGH THE TROCAR THE PRODUCT PULLED APART AND THE MESH WAS TORN. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7011234 ↗
• MalfunctionNov 8, 2017Degraded; Degraded

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CASE, EVERY TIME THE SURGEON PLACED THE DEVICE THROUGH THE TROCAR, THE PRODUCT PULLED APART AND THE MESH WAS TORN. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7011081 ↗
• MalfunctionNov 6, 2017Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER: WHEN THE PACKAGING FOR THE PATCH WAS OPENED, THE PATCH WAS CRACKING BETWEEN THE FINGERS OF THE NURSE WHEN TAKING IT OUT. IT WAS VERY DRY AND BROKE INTO PIECES BEFORE IT COULD BE LAID DOWN. THE CASE WAS COMPLETED USING A NEW PATCH.

  Patient problems: No Patient Involvement

  MAUDE report 7004572 ↗
• MalfunctionAug 15, 2017Torn Material; Torn Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE MESH WAS DAMAGED, IT WAS FLAKY AND CRUMBLING ON TOUCH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6795369 ↗
• MalfunctionAug 15, 2017Torn Material; Torn Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE MESH WAS DAMAGED, IT WAS FLAKY AND CRUMBLING ON TOUCH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6794525 ↗