PROMARK APEX LOCATOR V841113000000Recalls & reported problems
VDW GmbH · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This VDW ProMark Apex locator, a dental tool that measures root canal length, has 106 reports, with no deaths and no injuries. Nearly all reports describe the device giving incorrect measurements, and some involve the related Raypex locator. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 106
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI E225V8411130000001), received between Jun 2, 2023 and Jun 3, 2026 — classified as 106 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (105 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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement105
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions85
- Insufficient Information28
- Pain2
- Swelling/ Edema1
Recent adverse event reports
The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2026Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GIVING INCORRECT MEASUREMENTS. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25372436 ↗MalfunctionApr 7, 2026Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GIVING INCORRECT MEASUREMENTS. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799704 ↗MalfunctionApr 7, 2026Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A RAYPEX 6 APEX LOCATOR GIVING INCORRECT MEASUREMENTS. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24799497 ↗MalfunctionApr 1, 2026Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A RAYPEX 6 GIVING INCORRECT MEASUREMENTS. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24754022 ↗MalfunctionMar 23, 2026Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GIVING INCORRECT MEASUREMENTS. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24663156 ↗MalfunctionMar 4, 2026Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GIVING INCORRECT MEASUREMENTS. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24511481 ↗MalfunctionFeb 26, 2026Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A RAYPEX 6 GIVING INCORRECT MEASUREMENTS. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24454126 ↗MalfunctionJan 21, 2026Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A RAYPEX 6 DEVICE MALFUNCTIONED, GAVE INCORRECT MEASUREMENTS. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24129799 ↗MalfunctionJan 9, 2026Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GAVE INCORRECT MEASUREMENTS. IT WAS INITIAL REPORTED THAT NO MEASUREMENT WAS POSSIBLE WITH PROMARK APEX LOCATOR. HOWEVER, ON THE ACCOMPANYING LETTER THAT WAS ENCLOSED WITH THE DEVICE WHEN IT WAS SENT IN FOR INVESTIGATION, THE CUSTOMER STATED ¿INCORRECT MEASUREMENT¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019537 ↗MalfunctionJan 7, 2026Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GAVE INCORRECT MEASUREMENTS. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23988851 ↗MalfunctionJan 6, 2026Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A RAYPEX 6 GAVE INCORRECT MEASUREMENTS. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23973479 ↗MalfunctionDec 16, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A RAYPEX 6 GAVE INCORRECT MEASUREMENTS. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23819114 ↗MalfunctionDec 12, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GAVE INCORRECT MEASUREMENTS. THE OUTCOME IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23788362 ↗MalfunctionDec 5, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A RAYPEX 6 APEX LOCATOR GAVE INCORRECT MEASUREMENTS. DOCTOR REPORTED THE CONNECTION BETWEEN THE PROBE AND THE HOST BECOMES LOOSE. THE EQUIPMENT DISPLAYED A SUDDEN DRIFT IN VALUES, WHICH REMAINED INACCURATE EVEN AFTER MULTIPLE CALIBRATIONS, RESULTING IN EXCESSIVE PREPARATION OF THE CANAL AND CAUSING SWELLING AND PAIN AROUND THE PATIENT'S PERIAPICAL AREA.
Patient problems: Pain; Swelling/ Edema
MAUDE report 23728243 ↗MalfunctionDec 5, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GAVE INCORRECT MEASUREMENTS. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23728151 ↗MalfunctionDec 5, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GAVE INCORRECT MEASUREMENTS. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23728043 ↗MalfunctionDec 5, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A RAYPEX 6 APEX LOCATOR GAVE INCORRECT MEASUREMENTS. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23727658 ↗MalfunctionNov 17, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A RAYPEX 6 APEX LOCATOR GAVE INCORRECT MEASUREMENTS. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23568368 ↗MalfunctionOct 16, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GIVING INCORRECT MEASUREMENTS. NO INJURY OCCURRED. THE CUSTOMER MISTAKENLY SENT THE DEVICE TO THE WRONG DEPARTMENT AND THE DEVICE WAS DESTROYED AND DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23308633 ↗MalfunctionSep 3, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT WAS REPORTED THAT A PROMARK APEX LOCATOR GAVE INCORRECT MEASUREMENTS; NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22954304 ↗MalfunctionSep 3, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GAVE INCORRECT MEASUREMENTS. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR.
Patient problems: Insufficient Information
MAUDE report 22954179 ↗MalfunctionAug 14, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GAVE INCORRECT MEASUREMENTS AND SOMETIMES DOES NOT READ AT ALL. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22802878 ↗MalfunctionMar 27, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROMARK APEX LOCATOR GAVE INCORRECT OVER MEASUREMENTS. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21706639 ↗MalfunctionMar 12, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT A PROPEX PIXI EUR WAS GIVING INCORRECT MEASUREMENTS. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21584557 ↗MalfunctionMar 5, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT PROMARK APEX LOCATOR GAVE INCORRECT MEASUREMENTS. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21527204 ↗
Other Locator, root apex devices
- X-Smart Pro 6779016SIRONA Dental Systems GmbH · Locator, root apex4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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