Maxima 5702094Recalls & reported problems
Henry Schein, Inc. · Maxima PRO 2L AR Highspeed Handpiece · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00304040133682), received between Mar 14, 2024 and Oct 17, 2024 — classified as 4 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component4
- Accessory Incompatible2
- Component Incompatible2
- Material Integrity Problem2
Patient problems
- Insufficient Information6
- Laceration(s)2
- Pain2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2024Material Integrity Problem; Material Integrity Problem
HANDPIECES (B)(4) FELL APART WHILE BEING USED ON PATIENTS.
Patient problems: Insufficient Information
MAUDE report 20469030 ↗InjuryAug 28, 2024Material Integrity Problem; Material Integrity Problem
HANDPIECES FELL APART WHILE BEING USED ON PATIENTS.
Patient problems: Insufficient Information
MAUDE report 20087020 ↗MalfunctionMay 3, 2024Accessory Incompatible; Component Incompatible; Accessory Incompatible; Component Incompatible
BUR USED IN HANDPIECE BENT WHILE IN USE AND INJURED PATIENT.
Patient problems: Laceration(s)
MAUDE report 19236008 ↗InjuryApr 2, 2024Accessory Incompatible; Component Incompatible; Accessory Incompatible; Component Incompatible
BUR USED IN HANDPIECE BENT WHILE IN USE AND INJURED PATIENT.
Patient problems: Laceration(s)
MAUDE report 19020124 ↗MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
HANDPIECE BURST IN PATIENTS MOUTH LEADING TO MINOR INJURY.
Patient problems: Insufficient Information
MAUDE report 18909982 ↗MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
HANDPIECE BURST IN PATIENTS MOUTH LEADING TO MINOR INJURY.
Patient problems: Insufficient Information
MAUDE report 18909981 ↗InjuryMar 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
HANDPIECE BURST IN PATIENTS MOUTH LEADING TO MINOR INJURY.
Patient problems: Insufficient Information; Pain
MAUDE report 18903740 ↗InjuryMar 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
HANDPIECE BURST IN PATIENTS MOUTH LEADING TO MINOR INJURY.
Patient problems: Insufficient Information; Pain
MAUDE report 18903664 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.