ARISTA SM0007-USARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741044144), received between Jun 13, 2017 and Feb 10, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, APPROXIMATELY 3 G OF THE 5 G ARISTA AH WAS USED DURING A THYROIDECTOMY PROCEDURE ON (B)(6) 2023. THE SURGEON STATED THE RESIDUAL ARISTA AH MATERIAL WAS NOT REMOVED BY IRRIGATION OR ANY OTHER METHODS. AS REPORTED, THE PATIENT DEVELOPED PURULENCE LESS THAN 24 HOURS POST OP; THEREBY THE PATIENT WAS TAKEN BACK TO THE OR ON (B)(6) 2023 FOR NECK SWELLING, REDNESS, PAIN AND EVACUATION OF PURULENCE WAS PERFORMED. IT WAS ALSO REPORTED THAT THE PATIENT WAS STARTED ON PROPHYLACTIC ANTIBIOTICS AND THE CULTURES WERE STERILE.

  Patient problems: Erythema; Pain; Purulent Discharge; Swelling/ Edema

  MAUDE report 16345551 ↗
• InjuryDec 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, ARITA AH WAS USED ON THE VAGINAL CUFF AND RESIDUAL MATERIAL WAS NOT REMOVED AFTER HEMOSTASIS WAS ACHIEVED. AS REPORTED, THE PATIENT DEVELOPED WITH VAGINAL CUFF ABSCESS. IT WAS ALSO REPORTED THAT PATIENT IS PRESENTED TO THE EMERGENCY DEPARTMENT VISITS ON SEVERAL OCCASIONS AND THE PATIENT IS DOING WELL AT THIS TIME.

  Patient problems: Abscess

  MAUDE report 15982980 ↗
• InjuryDec 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A PROCEDURE, ARITA AH WAS USED ON THE VAGINAL CUFF AND RESIDUAL MATERIAL WAS NOT REMOVED AFTER HEMOSTASIS WAS ACHIEVED. AS REPORTED, THE PATIENT DEVELOPED WITH VAGINAL CUFF ABSCESS. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT 2 SUBSEQUENT SURGERIES, AND THE PATIENT IS DOING WELL AT THIS TIME.

  Patient problems: Abscess

  MAUDE report 15982625 ↗
• InjuryDec 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, ARITA AH WAS USED ON THE VAGINAL CUFF AND RESIDUAL MATERIAL WAS NOT REMOVED AFTER HEMOSTASIS WAS ACHIEVED. AS REPORTED, THE PATIENT DEVELOPED WITH VAGINAL CUFF ABSCESS. IT WAS ALSO REPORTED THAT PATIENT IS PRESENTED TO THE EMERGENCY DEPARTMENT VISITS ON SEVERAL OCCASIONS AND THE PATIENT IS DOING WELL AT THIS TIME.

  Patient problems: Abscess

  MAUDE report 15982577 ↗
• InjuryJun 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A GYNECOLOGICAL PROCEDURE TO REMOVE CYSTS FIBROIDS AND ADHESIONS, BARD ARISTA AH WAS USED IN CONJUNCTION WITH AN AUTO TRANSFUSION DEVICE. THE CASE WAS COMPLETED AND THE PATIENT WAS TAKEN TO RECOVERY IN WHICH AFTER ABOUT 15 MINUTES BEGAN TO EXHIBIT INCREASED HEART RATE, HYPOTENSION, LOW URINE OUTPUT AND PULMONARY EDEMA. THE PATIENT WAS TAKEN TO ICU WHERE SHE WAS STABILIZED AND CONTINUES TO BE ON ASSISTED VENTILATION. THE SURGEON HAS REQUESTED A DOCTOR TO DOCTOR CONSULT.

  Patient problems: Low Blood Pressure/ Hypotension; Pulmonary Edema; Renal Failure

  MAUDE report 6637382 ↗