SAMBA 2 Hi AP unit, left 52529Recalls & reported problems

Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Audio Processor · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09008737525293), received between Jul 25, 2022 and Jul 25, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Device problems

Fluid/Blood Leak1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionJul 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
A RONDO 3 CONTROL UNIT WITH A CRACKED HOUSING AND LEAKING BATTERY WAS RECEIVED AT SERVICE AND REPAIR. PER REPAIR REQUEST FORM, THE DEVICE WAS RETURNED DUE TO BEING NON-FUNCTIONAL. NO INJURY HAS BEEN REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15093866 ↗

Device details

UDI-DI	`09008737525293`
Brand	SAMBA 2 Hi AP unit, left
Model	52529
Company	Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Product code	MPV · Implant, Hearing, Active, Middle Ear, Partially Implanted
Class	Class 3
FDA submission	P990052
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jun 20, 2023

Device type (GMDN): Partially-implantable middle ear implant system sound processor

The non-sterile external portion of a partially-implantable middle ear implant system that typically consists of a battery-powered microphone, signal analysis and filtering unit, radio-frequency (RF) modulator and amplifier, and an RF transmitter and antenna. These components receive sound waves from the environment, convert them into electrical signals (radio waves), and transmit the signals to the implantable portion of the system which activates the auditory pathway by vibrating the ossicles (middle ear bones).

Other Implant, Hearing, Active, Middle Ear, Partially Implanted devices

SAMBA 2 Hi User Kit, Left 52614
Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Hearing, Active, Middle Ear, Partially Implanted
1 report

All Implant, Hearing, Active, Middle Ear, Partially Implanted devices →

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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