XIA 48047070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327263398), received between Jul 8, 2016 and Dec 21, 2016 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT BLOCKER INSERTER WAS BROKEN DURING THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6196243 ↗
• MalfunctionAug 18, 2016Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; THE BLOCKER INSERTER WAS BROKEN DURING THE SURGERY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 5885755 ↗
• MalfunctionJul 8, 2016Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; THAT "THE BLOCKER INSERTER WAS BROKEN DURING THE SURGERY. SPARE BLOCKER INSERTER WAS USED, BROKEN PARTS WERE COLLECTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5780198 ↗