ARISTA SM0002-USARecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741044106), received between Mar 21, 2019 and Jul 28, 2026 — classified as 19 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Patient-Device Incompatibility

  As reported, during a cholecystitis procedure, Arista AH was applied to the hepatic fossa, which was bleeding during dissection. Reportedly, fifteen (15) minutes later, while irrigating the wound, erythematous papules were observed on the patient's left and right flanks and lower abdomen. There were no changes in vital signs or other parameters. Medication was implemented on the spot to alleviate the hives. Residual material was removed, the patient was discharged after the hives subsided. The patient's condition has progressed favorably. It is unclear whether the hives were an allergic reaction to Arista AH, but the only deviation from standard supplies was the use of Arista.

  Patient problems: Rash

  MAUDE report 50059451 ↗
• InjuryJul 17, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER MEDWATCH FORM (MW5155891): "HERNIA MESH IMPLANT RESULTING IN INFECTION REVISION SURGERY AND PROLONGED INFECTION. CR BARDMESH HRNA REPAIR 25CMX31CM IMPLANT TYPE: MESH/PEG, IMPLANTED AREA: ABDOMEN LATERALITY: IMPLANTED ON (B)(6) 2023. NUMBER IMPLANTED: 1 STATUS: IMPLANTED, MANUFACTURER CR BARD, MODEL NUMBER: 1190500, LOT NUMBER: HUGZ0902, SERIAL NUMBER: SEALNT PWDR HEMOS 3GM ARISTA IMPLANT TYPE SEALANT IMPLANTED AREA: ABDOMEN LATERALITY: N/A IMPLANTED ON (B)(6) 2023. NUMBER IMPLANTED: 2 MEDICAL CENTER REVISION SURGERY (B) (6) AFTER MRI AND BLOODWORK SHOWED ABDOMINAL INFECTION. HOSPITALIZED THIRD TIME (B)(6) WITH RECURRING INFECTION. BLOOD WORK AND ANTIBIOTICS FOR THREE DAYS." THIS FILE REPRESENTS THE ARISTA AH.

  Patient problems: Unspecified Infection

  MAUDE report 19761177 ↗
• MalfunctionJun 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, "RARP IMPLEMENTED 2 WEEKS AGO. IT WAS REPORTED THAT THERE WAS SOME OOZING AROUND THE CLOSURE HOLE AND FINISHED WITHOUT CLEANING. IT WAS REPORTED THAT THERE WAS A STRONG ADHESION IN THE MESENTERY OF THE SMALL INTESTINE. IT WAS REPORTED THAT THE SURGEON THAT IT WAS NOT CAUSED BY ARISTA BECAUSE IT WAS ABSORBED IN 48 HOURS. THE PROBLEM HAS BEEN RESOLVED AS OF NOW." IT WAS REPORTED THAT THE SURGEON IS AN EXPERIENCED USER.

  Patient problems: Insufficient Information

  MAUDE report 19604081 ↗
• InjuryNov 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE: "EFFECT OF MICROPOROUS POLYSACCHARIDE HEMOSPHERES ON ANTEROLATERAL THIGH FREE FLAP DONOR SITE COMPLICATIONS." THE AIM OF THE STUDY WAS TO DETERMINE IF THE APPLICATION OF MPH (ARISTA AH) DURING CLOSURE OF THE ALT DONOR SITE REDUCES POSTOPERATIVE DRAIN OUTPUTS AS WELL AS SEROMA OR HEMATOMA FORMATION. THIS STUDY DESCRIBES PROSPECTIVE, SINGLE-BLIND, RANDOMIZED CONTROLLED TRIAL OF PATIENTS UNDERGOING FASCIOCUTANEOUS ALT HARVEST FOR HEAD AND NECK RECONSTRUCTION AT A TERTIARY ACADEMIC MEDICAL CENTER BETWEEN APRIL 2018 AND FEBRUARY 2020. 62 PATIENTS WERE ENROLLED IN THE STUDY WHICH INCLUDES 34 PATIENTS TO THE INTERVENTION GROUP AND 28 TO THE CONTROL GROUP. IN TOTAL, 55 PATIENTS WERE ANALYZED AND NOTED THAT 29 PATIENTS IN THE INTERVENTION GROUP (MPH) AND 26 PATIENTS IN THE CONTROL GROUP (NO-MPH). THE INTERVENTION GROUP RECEIVED A 3 G DOSE OF MPH (ARISTA AH). IN MPH GROUP, THE MEAN DRAIN OUTPUT WAS 284.7 ± 153.0 ML, AND THE SURGICAL DRAINS WERE REMOVED AFTER A MEAN OF 5.9 ± 1.5 DAYS. WITHIN 6 MONTHS POSTOPERATIVELY, PATIENT HAD SEROMA (6), HEMATOMA (2) AND DONOR SITE INFECTION (2). THERE WAS NO SIGNIFICANT DIFFERENCE IN SEROMA, HEMATOMA, OR INFECTION. DRAIN OUTPUT WAS NO

  Patient problems: Hematoma; Seroma; Unspecified Infection

  MAUDE report 18184801 ↗
• InjuryOct 20, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A BREAST SURGERY IN (B)(6) 2023 DURING WHICH 2- 3ML OF ARISTA AH HAD BEEN USED. THE SURGEON, ON (B)(6) 2023, HAD TO DO A RE-EXCISION. IT WAS REPORTED THE PATIENT HAD FOREIGN BODY RESPONSE WITH "ENCAPSULATED" ARISTA AH MATERIAL. THE SURGEON¿S QUERY WAS TO ASCERTAIN IF USERS HAD EVER ENCOUNTERED SUCH A ¿RESPONSE¿ WITH USE OF ARISTA. PATHOLOGY FROM THE SURGERY WAS ONLY SPECIFIC TO ¿NON-MALIGNANT TISSUE.¿ THE SURGEON CONFIRMED THE RESIDUAL ARISTA AH MATERIAL HAD NOT BEEN REMOVED FROM THE SURGICAL SITE AS RECOMMENDED IN THE IFU. IT WAS REPORTED THAT THE PATIENT IS NOW DOING WELL WITH NO APPARENT ADVERSE RESPONSE.

  Patient problems: Foreign Body Reaction

  MAUDE report 17974625 ↗
• InjurySep 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A SURGEON REPORTED THAT AFTER USING ARISTA IN 3 THYROIDECTOMY SURGERIES, HIS PATIENTS PRESENTED HYPOPARATHYROIDISM, WHICH AFTER ABOUT 3 MONTHS GOT NORMALIZED. THESE PATIENTS DID NOT HAVE THIS DISABILITY PRIOR TO THE PROCEDURE AND/OR USE OF ARISTA. PATIENT WAS PROVIDED WITH PARATHYROID HORMONE (PTH) ON THE FOLLOWING DAY. THE HYPOPARATHYROIDISM WERE REPORTED TO HAVE NORMALIZED ABOUT 3 MONTHS LATER. THIS MDR REPRESENTS CASE/PATIENT 3.

  Patient problems: Hormonal Imbalance; Hypocalcemia

  MAUDE report 17735512 ↗
• InjurySep 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A SURGEON REPORTED THAT AFTER USING ARISTA IN 3 THYROIDECTOMY SURGERIES, HIS PATIENTS PRESENTED HYPOPARATHYROIDISM, WHICH AFTER ABOUT 3 MONTHS GOT NORMALIZED. THESE PATIENTS DID NOT HAVE THIS DISABILITY PRIOR TO THE PROCEDURE AND/OR USE OF ARISTA. PATIENT WAS PROVIDED WITH PARATHYROID HORMONE (PTH) ON THE FOLLOWING DAY. THE HYPOPARATHYROIDISM WERE REPORTED TO HAVE NORMALIZED ABOUT 3 MONTHS LATER. THIS MDR REPRESENTS CASE/PATIENT 2.

  Patient problems: Hormonal Imbalance; Hypocalcemia

  MAUDE report 17735504 ↗
• InjurySep 12, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A SURGEON REPORTED THAT AFTER USING ARISTA IN 3 THYROIDECTOMY SURGERIES, HIS PATIENTS PRESENTED HYPOPARATHYROIDISM, WHICH AFTER ABOUT 3 MONTHS GOT NORMALIZED. THESE PATIENTS DID NOT HAVE THIS DISABILITY PRIOR TO THE PROCEDURE AND/OR USE OF ARISTA. PATIENT WAS PROVIDED WITH PARATHYROID HORMONE (PTH) ON THE FOLLOWING DAY. THE HYPOPARATHYROIDISM WERE REPORTED TO HAVE NORMALIZED ABOUT 3 MONTHS LATER. ADDENDUM PER ADDITIONAL INFORMATION: IT WAS REPORTED THAT THYROIDECTOMY SURGERIES WERE DONE ON (B)(6) 2023. AS REPORTED ON DAY 1 POST OPERATION, THE PATIENT WAS EXAMINED WITH PARATHYROID HORMONE AND CALCIUM DOSAGE WHICH DETECTED HYPOPARATHYROIDISM. IT WAS ALSO REPORTED THAT THE PATIENT HAD SYMPTOMS OF HYPOCALCEMIA, THEREFORE PRESCRIBED WITH ORAL CALCITONIN AND CALCIUM. IT WAS REPORTED THAT THE RESIDUAL MATERIAL OF ARISTA AH WAS NOT REMOVED FROM PATIENTS. THIS MDR REPRESENTS CASE/PATIENT 1.

  Patient problems: Hormonal Imbalance; Hypocalcemia

  MAUDE report 17730833 ↗
• InjuryAug 7, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A TOTAL HYSTERECTOMY SURGERY, 3 GRAMS OF ARISTA AH WAS USED AT THE PELVIC FLOOR AND LYMPH NODE DISSECTION SITES. THE PATIENT DEVELOPED INFECTION AFTER THE SURGERY. IT WAS ALSO REPORTED THAT AFTER THE INFECTION THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 17468978 ↗
• InjuryJul 26, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY SURGERY, ARISTA AH AND ADSPRAY (ADHESION BARRIER) WERE USED AT THE FINAL LYMPHADENECTOMY SITE. IT WAS REPORTED THAT TWO WEEKS POST USAGE, THE PATIENT PRESENTED TO THE OUTPATIENT CLINIC WITH AN INFECTION. AS REPORTED PER SURGEON THE SOURCE OF THE INFECTION WAS NOT KNOWN AND COULD NOT BE IDENTIFIED.

  Patient problems: Unspecified Infection

  MAUDE report 17395432 ↗
• InjuryDec 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WITH COMORBIDITY UNDERWENT TUMOR RESECTION SURGERY. AS REPORTED, EXCESS BLOOD WAS REMOVED FROM THE SITE, ARISTA AH WAS USED, DIRECT PRESSURE WAS APPLIED AND EXCESS ARISTA AH WAS REMOVED FROM THE SURGICAL SITE. AS REPORTED, THE PATIENT SHOWED SIGN AND SYMPTOMS OF SEPSIS 24 HOURS AFTER THE PROCEDURE, MEDICAL INTERVENTION WAS PROVIDED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Fever; Sepsis

  MAUDE report 16016348 ↗
• InjuryDec 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WITH COMORBIDITY UNDERWENT TUMOR RESECTION SURGERY. AS REPORTED, EXCESS BLOOD WAS REMOVED FROM THE SITE, ARISTA AH WAS USED, DIRECT PRESSURE WAS APPLIED AND EXCESS ARISTA AH WAS REMOVED FROM THE SURGICAL SITE. AS REPORTED, THE PATIENT SHOWED SIGN AND SYMPTOMS OF SEPSIS 24 HOURS AFTER THE PROCEDURE, MEDICAL INTERVENTION WAS PROVIDED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Fever; Sepsis

  MAUDE report 16016343 ↗
• InjuryDec 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WITH COMORBIDITY UNDERWENT TUMOR RESECTION SURGERY. AS REPORTED, EXCESS BLOOD WAS REMOVED FROM THE SITE, ARISTA AH WAS USED, DIRECT PRESSURE WAS APPLIED AND EXCESS ARISTA AH WAS REMOVED FROM THE SURGICAL SITE. AS REPORTED, THE PATIENT SHOWED SIGN AND SYMPTOMS OF SEPSIS 24 HOURS AFTER THE PROCEDURE, MEDICAL INTERVENTION WAS PROVIDED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Fever; Sepsis

  MAUDE report 16016342 ↗
• InjuryDec 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WITH COMORBIDITY UNDERWENT TUMOR RESECTION SURGERY. AS REPORTED, EXCESS BLOOD WAS REMOVED FROM THE SITE, ARISTA AH WAS USED, DIRECT PRESSURE WAS APPLIED AND EXCESS ARISTA AH WAS REMOVED FROM THE SURGICAL SITE. AS REPORTED, THE PATIENT SHOWED SIGN AND SYMPTOMS OF SEPSIS 24 HOURS AFTER THE PROCEDURE, MEDICAL INTERVENTION WAS PROVIDED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Fever; Sepsis

  MAUDE report 16016341 ↗
• InjuryDec 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WITH COMORBIDITY UNDERWENT TUMOR RESECTION SURGERY. AS REPORTED, EXCESS BLOOD WAS REMOVED FROM THE SITE, ARISTA AH WAS USED, DIRECT PRESSURE WAS APPLIED AND EXCESS ARISTA AH WAS REMOVED FROM THE SURGICAL SITE. AS REPORTED, THE PATIENT SHOWED SIGN AND SYMPTOMS OF SEPSIS 24 HOURS AFTER THE PROCEDURE, MEDICAL INTERVENTION WAS PROVIDED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Fever; Sepsis

  MAUDE report 16016338 ↗
• InjuryNov 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT DEVELOPED FEVER AND SEPSIS POST-USAGE OF BARD/DAVOL ARISTA AH.

  Patient problems: Fever; Sepsis

  MAUDE report 15860148 ↗
• MalfunctionJun 16, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2022, THE PATIENT DEVELOPED EPIDURAL HEMATOMA POST SURGERY USING THE BARD/DAVOL ARISTA AH. IT IS UNKNOWN WHETHER THE RESIDUAL MATERIAL WAS REMOVED THROUGH IRRIGATION OR OTHER METHOD. IT WAS ALSO REPORTED THAT THE ARISTA AH WAS NATURALLY ABSORBED AND THE PATIENT'S SYMPTOMS RECOVERED.

  Patient problems: Hematoma

  MAUDE report 14712813 ↗
• MalfunctionJun 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED, DURING A CARDIAC SURGERY ON (B)(6) 2021 BARD/DAVOL ARISTA AH 3G US WAS USED ON THE PATIENT. THE ARISTA WAS NOT IN A POWDERY FORM, AS IS NORMAL. IT WAS IDENTIFIED AS CAKE-LIKE, CLUMPY, AND THICK. THE SURGEON UTILIZED THIS DURING SURGERY BUT HEMOSTASIS WAS NOT ACHIEVED. AS REPORTED, THE ARISTA AH MATERIAL WAS IN A DRY STATE AND DID NOT COME IN CONTACT WITH ANY FLUIDS BEFORE DEPLOYMENT. ANOTHER FROM THE SAME LOT WAS OPENED, DEPLOYED ONTO A SURGICAL TOWEL AND NOTED THE SAME CONSISTENCY. ANOTHER ARISTA AH WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS EVENT. AS THE ARISTA AH USED DID NOT ACHIEVE HEMOSTASIS A MALFUNCTION MDR IS SUBMITTED TO DOCUMENT THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058355 ↗
• InjuryOct 21, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, ON (B)(6) 2020, THE PATIENT EXPERIENCED BRISK BLEEDING DURING A ZENKER¿S DIVERTICULUM (ESOPHAGEAL DIVERTICULUM) CASE AND A 3G ARISTA AH WAS USED AND HEMOSTASIS WAS ACHIEVED. THE SURGEON COULD NOT USE IRRIGATION AROUND THE IMPLANT, BUT USED SUCTION TO REMOVE THE RESIDUAL MATERIAL. THE PATIENT WAS RELEASED AND LATER EXPERIENCED POST-OP SWELLING OF THE TONGUE A FEW HOURS AFTER SURGERY. THE PATIENT REQUIRED TREATMENT AT AN ER AND WAS INTUBATED, AFTER WHICH, THE PATIENT WAS REPORTED TO BE RECOVERING AND DOING WELL. DOCTOR IDENTIFIED THAT THE PATIENT WAS ON LISINOPRIL AND BLOOD PRESSURE MEDICATION AND STATED THAT THE PATIENT IS A LONG-TIME USER AND HAS NOT EXPERIENCED ANY SIMILAR EVENTS AND CONSIDERED A REACTION TO ARISTA AH TO BE UNLIKELY IN THIS CASE. THE IDENTIFIED RESPONSE WAS POSSIBLY EXPECTED DUE TO OTHER MEDICATIONS THE PATIENT WAS TAKING FOR HYPERTENSION.

  Patient problems: Airway Obstruction; Edema; Swelling

  MAUDE report 10710814 ↗
• InjurySep 20, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ABSCESS THAT REQUIRED ANTIBIOTICS AND DRAINAGE POST-OPERATIVELY AFTER USE OF THE ARISTA AH PRODUCT. THE SURGEON IS A FIRST-TIME USER OF THE ARISTA.

  Patient problems: Abscess

  MAUDE report 9099818 ↗
• InjuryAug 19, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SUBTOTAL PARATHYROIDECTOMY WHERE A ¿MEDIUM¿ AMOUNT OF ARISTA WAS USED. THE MD STATES THE PATIENT EXPERIENCED SOME VOCAL CORD DAMAGE, BUT IS UNSURE IF THIS IS RELATED TO THE ARISTA. AS REPORTED, THE SURGEON, A FIRST-TIME USER, ¿IS CERTAIN HE DID NOT CUT THE RLNS (RECURRENT LATERAL NERVES) AS HE SAW BOTH NERVES AND PRESERVED THEM DURING THE SURGERY.¿ AS REPORTED, THE PATIENT HAD AN IMMEDIATE POST-OPERATIVE COMPLICATION OF BILATERAL RECURRENT LARYNGEAL NERVE PALSY REQUIRING A TRACHEOSTOMY WITH NO RESOLUTION TO THE VOCAL CORD DAMAGE TO DATE. THE PATIENT WAS DISCHARGED AFTER 2 WEEKS TO A CONVALESCENT HOME LOCALLY. THE SURGEON REPORTS THAT THE PATIENT DOES NOT HAVE ANY KNOWN ALLERGIES OR ANY KNOWN DEFECTS TO THEIR CLOTTING SYSTEM. DURING THE PROCEDURE, NO OTHER HEMOSTATIC AGENTS / PRODUCTS WERE USED AND THE SURGEON ONLY USED LIGHT PRESSURE USING A GAUZE SPONGE AFTER THE APPLICATION OF THE ARISTA TO ACHIEVE HEMOSTASIS. EXCESS ARISTA WAS REMOVED WAS FROM THE SITE WITH NO OTHER COMPLICATING FACTORS IN THE PROCEDURE. AS REPORTED, THIS WAS CONSIDERED A CLEAN PROCEDURE WITH NO PURULENT MATERIAL PRESENT IN THE WOUND AT THE TIME OF USE. PATIENT IS EXP

  Patient problems: Nerve Damage

  MAUDE report 8906274 ↗
• InjuryMar 21, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ARISTA AH WAS USED IN A LAPAROSCOPIC HIATAL HERNIA AND TRANSORAL INCISIONLESS FUNDOPLICATION SURGICAL PROCEDURE IN WHICH THE PATIENT DEVELOPED AN ABSCESS. THERE WAS MINOR BRUISING TO THE LIVER CAPSULE, NO ACTIVE BLEEDING; THEREFORE, THERE WAS NO EXCESS BLOOD TO BE REMOVED PRIOR TO THE ARISTA AH APPLICATION. THE ARISTA AH WAS SPRAYED ON THE TOP LEFT LOBE OF THE LIVER AND UNDER IT. NO OTHER HEMOSTATIC AGENTS WERE USED. NO DIRECT PRESSURE WAS APPLIED AFTER APPLICATION OF THE ARISTA AH AS THE SURGEON STATES IT WAS NOT NEEDED. EXCESS ARISTA AH WAS NOT REMOVED FROM THE SITE AND THERE WERE NO COMPLICATING FACTORS WITH THIS PROCEDURE. THE CASE WAS CONSIDERED CLEAN-CONTAMINATED. THE ARISTA AH WAS NOT SPRAYED OR PLACED DIRECTLY INTO BLOOD VESSELS. THE PATIENT DID NOT HAVE ANY KNOWN DEFECTS IN THEIR CLOTTING SYSTEM PRIOR TO USE OF THE ARISTA AH. THE PATIENT IS DIABETIC. THE PATIENT WAS READMITTED 6 DAYS LATER WITH ANTERIOR AND POSTERIOR LIVER ABSCESSES IN THE AREA WHERE THE ARISTA WAS USED. THE PATIENT UNDERWENT A LAPAROSCOPIC DRAINAGE OF THESE LIVER ABSCESSES.

  Patient problems: Abscess

  MAUDE report 8440664 ↗