ARISTA SM0005-USARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741044120), received between Sep 19, 2018 and Feb 20, 2026 — classified as 1 death, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 16, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, FOREIGN MATERIAL LIKE HAIR WAS FOUND INSIDE THE PACKAGE OF ARISTA AH. IT WAS REPORTED THAT THERE WAS NO DAMAGE NOTED ON THE OUTER AND INNER PACKAGE WHEN RECEIVED, THE PRODUCT BOX WAS COMPLETELY SEALED PRIOR TO OPENING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553141 ↗
• MalfunctionNov 4, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, ON (B)(6) 2021 DURING A PROCEDURE, A HAIR WAS FOUND INSIDE THE STERILE PACKAGING OF ARISTA AH. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751518 ↗
• InjuryOct 21, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT WAS TREATED FOR THYROID CASE DURING WHICH 1G BELLOW OF ARISTA AH WAS USED AS A HEMOSTATIC AGENT. THE ARISTA AH WAS APPLIED TO THE SITE BUT THERE WAS NO ACTIVE BLEEDING. AS REPORTED, THE EXCESS ARISTA PRODUCT WAS NOT IRRIGATED OUT AFTER HEMOSTASIS. THE WOUND WAS CLOSED. THERE WERE NO IMMEDIATE COMPLICATIONS. A FEW DAYS FOLLOWING SURGERY THE PATIENT DEVELOPED POST OP RASH AND SWELLING OUTSIDE THE DRESSING AREA. IT WAS IN THE AREA OF THE NECK, CHEST AND EXTREMITIES. SURGEON STATED THAT IT FEELS THE ARISTA IS MOST LIKELY THE ISSUE. PATIENT WAS TREATED WITH PREDNISONE STEROIDS AND DOCTOR STATED THE PATIENT WAS SLOWLY IMPROVING. IT WAS IDENTIFIED THAT THERE WAS NO INFECTION. THE ISSUE WAS A SKIN RASH, REACTION TYPE RESPONSE. DOCTOR COULD NOT RULE OUT ARISTA AH AS A FACTOR BUT DID INDICATE THAT IT MAY HAVE BEEN RESPONSE TO BETADINE SKIN PREPARATION.

  Patient problems: Rash; Reaction

  MAUDE report 10711457 ↗
• DeathJul 9, 2020Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT (MALE (B)(6) YEARS) UNDERWENT A SURGERY FOR PACEMAKER PLACEMENT. ARISTA-AH HEMOSTAT WAS USED TO TREAT THE PATIENT DURING THE IMPLANT PROCEDURE. IN THE MIDDLE OF THE NIGHT ((B)(6) 2020) AFTER THE SURGERY, THE PATIENT'S CONDITION SUDDENLY GOT WORSE AND PATIENT DIED. THE LOCAL AFFILIATE WAS NOT ABLE TO OBTAIN A DEATH CERTIFICATE. THEY REPORT THAT THE USER FACILITY IDENTIFIED NO CAUSAL RELATIONSHIP BETWEEN THE PATIENT¿S DEATH AND THE USE OF ARISTA-AH.

  Patient problems: Death

  MAUDE report 10254927 ↗
• MalfunctionSep 19, 2018Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method

  IT WAS REPORTED PER THE BD SALES REP. THAT ABOUT A MONTH AGO, A SURGEON USED ARISTA FOR THE FIRST TIME IN A CERVICAL/SPINE PROCEDURE. THE CASE WAS CONSIDERED A LEAN CASE, WITH NO EXISTING INFECTION. THE ARISTA POWDER (1 GRAM) WAS DEPLOYED IN SMALL AMOUNTS IN MULTIPLE AREAS AND MANIPULATED, APPLYING PRESSURE WITH A WET COTTONOID (NEURO PATTY). THE ARISTA POWDER THEN BECAME FIRM AND PELLET LIKE AND HEMOSTASIS WAS NOT ACHIEVED. THE ARISTA WAS REMOVED FROM THE PATIENT AND ANOTHER FORM OF HEMOSTATIC AGENT WAS USED. THE CASE WAS COMPLETED WITH NO IMPACT OR HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7888833 ↗