NA 03.503.085Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10887587011967), received between Jun 8, 2021 and Jul 11, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2022Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UK AS FOLLOWS: IT WAS REPORTED THAT THE CARDIAC THEATRES NOTIFIED OF A VERY STIFF DEPTH GAUGE USED IN THE CARDIAC MUSCLE FIBERS (CMF.) THE THE ITEM IS UNUSABLE AND THE INNER COMPONENT SEEMS TO BE BENT. THERE WAS A 10 MINUTE PROCEDURAL DELAY. THIS REPORT IS FOR ONE (1) DEPTH GAUGE F/MATMAND MEAS-RANGE UP-TO 4. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976949 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 16 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960286 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR (1) DEPTH GAUGE. THIS IS REPORT 15 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960226 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 14 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960116 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 13 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960018 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 12 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959982 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR (1) DEPTH GAUGE. THIS IS REPORT 11 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959928 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 9 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959845 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 2 OF 16 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959323 ↗