Veriset HP0204ERecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 20884521082530), received between Apr 14, 2017 and Nov 27, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, THE DEVICE CRUMBLED WHEN IT WAS TAKEN OUT OF THE PACKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20802994 ↗
• MalfunctionAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BLEEDING OCCURRED IN THE PULMONARY CAVITY OF A PATIENT THAT COULD NOT BE STOPPED BY THE HEMOSTATIC PATCH. A PATCH FROM A DIFFERENT BATCH WAS USED AND THE BLEEDING STOPPED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19991969 ↗
• MalfunctionAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A VIDEO ASSISTED THORACOSCOPIC SURGERY (VATS) LOBECTOMY, THE HEMOSTATIC PATCH DID NOT PROVIDE HEMOSTASIS ON THE WOUND OF THE PATIENT. A SECOND PATCH WAS USED, BUT STILL WITHOUT SUCCESS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19991895 ↗
• MalfunctionAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL STUDY, FOLLOWING AN OPEN REVERSAL OF HARTMANNS PROCEDURE FOR PERFORATED DIVERTICULITIS WHEREIN A HEMOSTATIC PATCHES WERE USED, THE PATIENT HAD TO RETURN THE HOSPITAL DUE LEFT SIDED ABDOMINAL PAIN DUE TO COLLECTION NEARBY THE SPLEEN TEAR. IT WAS ALSO NOTED THAT THE PATIENT HAD TACHYCARDIA AND FEVERS AT HOME. THIS LED TO CONCOMITANT/ADDITIONAL TREATMENT. DIAGNOSTIC ANDCTAP (COMPUTED TOMOGRAPHY ARTERIAL PORTOGRAPHY) EXAM WERE PERFORMED WHICH CONFIRMED THE SMALL COLLECTION ANTERIOR ASPECT (AROUND) A SMALL SPLEEN TEAR. THE PATIENT'S BLOOD ALSO SHOWED RAISED INFLAMMATORY MARKERS. THE COLLECTION WAS TOO SMALL FOR DRAINAGE. THUS THEPATIENT WAS ABLE TO GO HOME THE SAME DAY ON ORAL ANTIBIOTICS AND ANALGESIA. THE PATIENT HAS BEEN SAFETY NETTED FOR WORSENING SYMPTOMS AND IS CURRENTLY RECOVERING.

  Patient problems: Abdominal Pain; Fever; Tachycardia; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 19968308 ↗
• MalfunctionAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL STUDY, FOLLOWING AN OPEN REVERSAL OF HARTMANN'S PROCEDURE FOR PERFORATED DIVERTICULITIS WHEREIN A HEMOSTATIC PATCHES WERE USED, THE PATIENT HAD TO RETURN TO THE HOSPITAL DUE TO LEFT SIDED ABDOMINAL PAIN DUE TO COLLECTION NEARBY THE SPLEEN TEAR. IT WAS ALSO NOTED THAT THE PATIENT HAD TACHYCARDIA AND FEVERS AT HOME. THIS LED TO CONCOMITANT/ADDITIONAL TREATMENT. DIAGNOSTIC AND CTAP (COMPUTED TOMOGRAPHY ARTERIAL PORTOGRAPHY) EXAM WERE PERFORMED WHICH CONFIRMED THE SMALL COLLECTION ANTERIOR ASPECT (AROUND) A SMALL SPLEEN TEAR. THE PATIENT'S BLOOD ALSO SHOWED RAISED INFLAMMATORY MARKERS. THE COLLECTION WAS TOO SMALL FOR DRAINAGE. THUS THE PATIENT WAS ABLE TO GO HOME THE SAME DAY ON ORAL ANTIBIOTICS AND ANALGESIA. THE PATIENT HAS BEEN SAFETY NETTED FOR WORSENING SYMPTOMS AND IS CURRENTLY RECOVERING.

  Patient problems: Abdominal Pain; Fever; Tachycardia; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 19949313 ↗
• MalfunctionMay 6, 2021Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE BLEEDING OCCURRED AT THE BASE OF THE LIVER WHEN THE GALL BLADDER WAS REMOVED. THE SURGEON DECIDED TO USE PATCH. WHEN THE PACKAGING WAS OPENED, THE PATCH WAS UNUSUALLY FIRMER THAN NORMAL. WHEN THE PATCH WAS INSERTED THROUGH THE TROCAR, THE PATCH CRUMBLED AND BROKE INTO PIECES. DIATHERMY WAS USED TO STOP THE BLEEDING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782685 ↗
• MalfunctionJun 20, 2018Degraded; Degraded

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATCHES FROM THIS BOXES, FELT REALLY CRUMBLY. IT WAS NOT EASY TO ROLL IT AROUND THE INSTRUMENT TO INSERT IT THROUGH A TROCAR COMPARED TO HOW IT USUALLY DOES. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7620891 ↗
• MalfunctionApr 19, 2018Degraded; Degraded

  ACCORDING TO THE REPORTER, DURING A ROBOTIC NEPHRON PROTECTOR PROCEDURE, AFTER OPENING THE PRODUCT, IT BECAME ROUGH IN A SHORT TIME. DEPENDING ON ITS HARDENING, A FRACTURE PRESENTED ITSELF ON THIS DEVICE. THE PRODUCT COULD NOT BE USED DUE TO QUICK DRYING AND BREAKING LEADING TO AN EXTENDED SURGICAL TIME. THEY REPLACED THE PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7443197 ↗
• MalfunctionJan 5, 2018Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WAS BROKEN AND CRUNCHING LIKE A TOAST WHEN THE SURGEON ROLL IT UP AROUND THE SHAFT OF THE LAPAROSCOPIC INSTRUMENT. DEVICE WAS STILL USED AND WORKED ON THE LIVER BED. IT WAS NORMALLY SMOOTH AND FLEXIBLE SO AFTER THE PROCEDURE THEY OPENED ANOTHER SAME DEVICE TO CHECK AND IT WAS THE USUAL DEVICE THAT EXPECTED. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7168894 ↗
• MalfunctionDec 15, 2017Break; Break

  ACCORDING TO THE REPORTER, POST-OPERATIVELY AN OPEN PROCEDURE, THE BROKE WHEN IT WAS INSERTED. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7122865 ↗
• 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 BROKEN IN SMALL PIECES WHEN TRYING TO ROLL IT. THE MATERIAL IS NOT FLEXIBLE ENOUGH.

  Patient problems: No Patient Involvement

  MAUDE report 7085796 ↗
• MalfunctionNov 21, 2017Degraded; Degraded

  ACCORDING TO THE REPORTER, THE PATCHES WERE TOTALLY DRY AND THEY WERE BREAKING DOWN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7048974 ↗
• MalfunctionNov 14, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SURGEON WENT TO USE THE DEVICE FOR A LAPAROSCOPIC APPROACH, THE PATCH BROKE "LIKE CRUNCHING TOAST". THEY SWITCHED TO A NEW LOT BUT IT HAD THE SAME ISSUE. THEY INSTEAD USED A NEW DEVICE FROM A DIFFERENT MANUFACTURER. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7027773 ↗
• MalfunctionNov 14, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SURGEON WENT TO USE THE DEVICE FOR A LAPAROSCOPIC APPROACH, THE PATCH BROKE "LIKE CRUNCHING TOAST". THEY SWITCHED TO A NEW LOT BUT IT HAD THE SAME ISSUE. THEY INSTEAD USED A NEW DEVICE FROM A DIFFERENT MANUFACTURER. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7027734 ↗
• MalfunctionOct 31, 2017Break; Torn Material; Noise, Audible; Break; Torn Material; Noise, Audible

  ACCORDING TO THE REPORTER: OCCURRED PRIOR TO A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE. WHEN THE PRODUCT WAS FOLDED AGAINST THE SHAFT OF THE INSTRUMENT TO BRING INTO THE ABDOMEN CAVITY, IT BROKE IN THE MIDDLE. IT SOUNDED LIKE CRUNCHING A TOAST. THIS OCCURRED PRIOR TO BEING INSERTED INTO THE ABDOMINAL CAVITY. NO PIECES WERE ABLE TO BE PROPERLY IMPLANTED. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6990792 ↗
• MalfunctionOct 13, 2017Break; Break

  ACCORDING TO THE REPORTER: DURING A GASTRIC SLEEVE RESECTION, THE DEVICE BROKE IN THE MIDDLE WHEN FOLDED AGAINST THE SHAFT OF THE INSTRUMENT TO BRING IT INTO THE ABDOMINAL CAVITY. THE DOCTOR USED FLOWSEAL IN ORDER TO COMPLETE THE PROCEDURE. THE PATIENT STATUS IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6947588 ↗
• MalfunctionAug 29, 2017Product Quality Problem; Torn Material; Product Quality Problem; Torn Material

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC GALLBLADDER PROCEDURE. SURGEON TRIED TO ROLL THE PRODUCT AROUND THE SHAFT OF A DISSECTING INSTRUMENT. THE PATCH BROKE INTO PIECES. OPENED A SECOND ONE FROM THE SAME LOT BUT THE SAME ISSUE OCCURRED. THE PATCH FEELS DRY AND IT WAS CRUNCHY. THE SURGEON THEN OPENED A LARGER PATCH AND CUT IT TO A SMALLER SIZE FOR THE LIVER, WHICH WORKED WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6827951 ↗
• MalfunctionApr 14, 2017Break; Break

  ACCORDING TO THE REPORTER, PRIOR USE, THE DEVICE BROKEN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6493076 ↗