ARISTARecalls & reported problems across all models

We found 6 models of ARISTA by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2017 and Jul 28, 2026 — classified as 1 death, 26 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (20 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 ARISTA problems

ARISTA models

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

• ARISTA SM0002-USA

  Agent, absorbable hemostatic, non-collagen based
  22 reports
• ARISTA SM0005-USA

  Agent, absorbable hemostatic, non-collagen based
  1 death8 reports
• ARISTA SM0007-USA

  Agent, absorbable hemostatic, non-collagen based
  5 reports
• ARISTA AM0005

  Agent, absorbable hemostatic, non-collagen based
  1 report
• ARISTA AM0010

  Agent, absorbable hemostatic, non-collagen based
  1 report
• ARISTA AM0004

  Agent, absorbable hemostatic, non-collagen based
  1 report

Recent ARISTA adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionFeb 20, 2026Device Contamination with Chemical or Other Material

  AS REPORT, DURING A PROCEDURE FOREIGN MATERIAL (LONG HAIR) WAS FOUND IN THE SPRAYED POWDER WHICH WAS INSIDE THE STERILE PACKAGE OF ARISTA AH. THE PRODUCT BOX WAS COMPLETELY SEALED BEFORE OPENING AND THERE WAS NO DAMAGE TO THE INNER PACKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401061 ↗
• MalfunctionJun 16, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, ONE UNIT OF ARISTA AH FLEXITIP APPLICATOR PACKAGING/POUCH WAS TORN AND UNUSABLE. A NEW UNIT WAS USED FOR THE PROCEDURE AND THE OUTER BOX WAS NOT DAMAGED. THIS WAS THE ONLY DAMAGED POUCH IN THE PRODUCT CARTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212795 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE: "MICROPOROUS POLYSACCHARIDE HEMOSPHERES FOR REDUCING POCKET HEMATOMAS AFTER CARDIAC DEVICE IMPLANTATION IN PATIENTS ON ANTITHROMBOTIC THERAPY." THE ARTICLE DESCRIBES A SINGLE-CENTER RETROSPECTIVE STUDY AIMED TO INVESTIGATE THE POTENTIAL BENEFITS OF USING (MICROPOROUS POLYSACCHARIDE HEMOSPHERES) MPH HEMOSTATIC AGENTS DURING (CARDIAC IMPLANTABLE ELECTRONIC DEVICES) CIED IMPLANTATIONS AS A PREVENTIVE MEASURE AGAINST POST-PROCEDURAL (POCKET HEMATOMA) PHS. THE STUDY CONDUCTED WITH 255 CONSECUTIVE JAPANESE PATIENTS WHO UNDERWENT CIED IMPLANTATION BETWEEN NOVEMBER 2017 AND APRIL 2022. PATIENTS WHO UNDERWENT CIED IMPLANTATION BETWEEN NOVEMBER 2017 AND NOVEMBER 2019 HAD CIED PROCEDURES WITHOUT MPH HEMOSTATIC AGENTS, WHILE PATIENTS FROM DECEMBER 2019 TO APRIL 2022 HAD CIED PROCEDURES WITH MPH HEMOSTATIC AGENTS (1G DOSE OF HEMOSTATIC AGENT). THE POSTOPERATIVE COMPLICATIONS OF ARISTA AH INCLUDE POCKET HEMATOMA WAS OBSERVED WITHIN 28 DAYS POST-OPERATION IN 9 PATIENTS WHO RECEIVED MPH HEMOSTATIC AGENTS AND IN 13 PATIENTS WITHOUT MPH HEMOSTATIC. THE ARTICLE CONCLUDES THAT THE FINDINGS OF THIS STUDY SUGGEST THAT THE INCORPORATION OF MPH HEMOSTATIC AGENTS INTO STANDARD PRACTICE

  Patient problems: Hematoma

  MAUDE report 22036927 ↗
• 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 ↗
• MalfunctionMar 29, 2024Incomplete or Missing Packaging; Incomplete or Missing Packaging

  AS REPORTED, THE SALES REP WAS AT THE HOSPITAL ASSISTING WITH CASES. IN BETWEEN CASES, NOTICED THE OR SUPPLY CLOSET WAS LOW ON FLEXITIP XL APPLICATORS. WHEN OPENED THE SEALED SHELF BOX FROM THE MAIN SUPPLY CLOSET, GRABBED SEVERAL APPLICATORS AND NOTICED ONE OF THE APPLICATORS WAS MISSING THE OUTER TYVEK POUCH (PRODUCT IS DOUBLE POUCHED). THE APPLICATOR WAS WITHIN THE INNER TYVEK POUCH, JUST MISSING THE SECOND OUTER POUCH, SO IT WAS SET ASIDE WITH A STAFF MEMBER, AND IT WAS DISCARDED AS A PRECAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002840 ↗
• MalfunctionDec 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING AN UNKNOWN PROCEDURE OF PRECLINICAL ANIMAL STUDY, SIX (6) BELLOWS OF ARISTA AH WERE OPENED AND WEIGHED PRIOR TO USE. IT WAS REPORTED THAT SMALL FLECKS OF TAN/BROWN SPECKS WERE NOTED WHEN THE WEIGHING THE PRODUCT. IT WAS ALSO REPORTED THAT THE POWDER WAS USED WITHOUT ANY ISSUES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364362 ↗
• 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 ↗

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