ABLATOR 7209659Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010470331), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2020Break; Break

  IT WAS REPORTED THAT AFTER A SUCCESSFULLY ROTATOR CUFF REPAIR PERFORMED ON (B)(6) 2017 WHERE A 5.5 HEALICOIL PK ANCHOR WAS USED, 2 WEEKS POST OPERATIVE VISIT WAS MADE AND X-RAYS WERE PERFORMED AND SHOWED A METALLIC FRAGMENT UNDERNEATH THE CUFF REPAIR SITE. THIS FRAGMENT WAS OBSERVED FOR APPROXIMATELY 1 YEAR ON SERIAL X-RAYS AND THERE WAS NO MIGRATION OF SYMPTOMS. A FEW MONTHS AGO THE PATIENT MADE A SUDDEN MOVE OF HIS ARM AND A JOINT PAIN BEGAN, X-RAYS AND MRIS WERE PERFORMED AND SHOWED THAT THE METALLIC BODY MOVED INTO THE GLENOHUMERAL JOINT. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 AND A ROUND PIECE OF METAL WAS FOUND AND REMOVED ARTHROSCOPICALLY FROM THE JOINT. THE PATIENT IS STABLE AND RECOVERING. NO FURTHER COMPLICATIONS REPORTED. RESULTS OF INVESTIGATION OF RELATED COMPLAINT FOR THE HEALICOIL, HAVE CONCLUDED THAT THERE WAS A METAL FRAGMENT THAT WAS FROM THE TIP OF A VULCAN ABLATOR PROBE INSTEAD OF THE HEALICOIL PK ANCHOR, WHICH MEANS THAT THIS HAD TO BE REMOVED FROM THE PATIENT.

  Patient problems: Arthralgia; No Information

  MAUDE report 10546579 ↗