VerisetRecalls & reported problems across all models

We found 2 models of Veriset by Covidien LP in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and Nov 27, 2024 — classified as 1 death, 8 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 Veriset problems

Veriset models

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

• Veriset HP0510E

  Agent, Absorbable Hemostatic, Non-Collagen Based
  1 death33 reports
• Veriset HP0204E

  Agent, Absorbable Hemostatic, Non-Collagen Based
  18 reports

Recent Veriset adverse event reports

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

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