PRONOVA 3725HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031004696), received between Nov 16, 2018 and Jan 5, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE BECAME DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13162963 ↗
• InjuryNov 16, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAROTID ENDARTERECTOMY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE CONTINUOUS SUTURE WAS PLACED ON THE CAROTID ARTERY. THREE TO FOUR HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED HEMORRHAGIC SHOCK AND A SECOND PROCEDURE WAS PERFORMED. THE SUTURE WAS FOUND BROKEN OTHER THAN THE KNOT. A DIFFERENT SUTURE WAS USED TO CLOSE THE ARTERY AND COMPLETE THE PROCEDURE. THE PATIENT HAS LIGHT PARALYTIC SYMPTOMS AND THE HOSPITALIZATION STAY WAS EXTENDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Paralysis; Shock

  MAUDE report 8078304 ↗