BCI 602 Kit 52483Recalls & reported problems
Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Bone Conduction Implant Kit · Class 2 · Implant
Quick summary
This MED-EL BCI 602 bone conduction implant helps people hear through bone vibration. Its 152 adverse event reports include 38 injuries and no deaths; many describe no sound output, and some mention hearing changes after MRI scans or skin tears and infections. Reports fell to 16 in the past 12 months from 53 before. 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
- 159
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 09008737524838), received between Aug 6, 2020 and Sep 28, 2026 — classified as 43 injuries, 116 malfunctions.
The most frequently reported specific device problem is “No Device Output” (89 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
- No Device Output89
- Device Appears to Trigger Rejection31
- Adverse Event Without Identified Device or Use Problem24
- Output Problem12
- Insufficient Device Problem Information11
- Improper or Incorrect Procedure or Method10
- Loose or Intermittent Connection6
- Noise, Audible6
Patient problems
- Failure of Implant75
- No Clinical Signs, Symptoms or Conditions39
- Skin Tears18
- Post Operative Wound Infection8
- Tissue Breakdown7
- Insufficient Information5
- Head Injury4
- Unspecified Infection4
Recent adverse event reports
The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Device Appears to Trigger Rejection
User presented in the emergency room with the BCI partially extruded. Device explantation is scheduled.
Patient problems: Skin Tears
MAUDE report 50914471 ↗InjurySep 28, 2026Device Appears to Trigger Rejection
User presented in the emergency room with the BCI partially extruded. Device explantation is scheduled.
Patient problems: Skin Tears
MAUDE report 50913642 ↗InjurySep 21, 2026Device Appears to Trigger Rejection
Approximately 15 days ago, the user began experiencing local pain and developed a wound at the implant site. Upon clinical examination, the physician observed exposure of the internal component.
Patient problems: Tissue Breakdown
MAUDE report 50840338 ↗MalfunctionAug 27, 2026Improper or Incorrect Procedure or Method
The user reports she gets minimal/ no sound from the implanted side after a 3.0 T MRI. She reports she has reached out to Audiologist to schedule follow up. She will discontinue use of SAMBA 2 until she is seen.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50473461 ↗InjuryJul 30, 2026No Device Output
The user could not hear anything. The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50080603 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
The user had a mastoid infection. The user was explanted.
Patient problems: Mastoiditis
MAUDE report 50035387 ↗MalfunctionJun 30, 2026No Device Output; Adverse Event Without Identified Device or Use Problem
DURING THE SCAN, HE EXPERIENCED SEVERE PAIN ON THE LEFT SIDE OF THE HEAD BUT DID NOT INTERRUPT THE EXAMINATION. AFTER LEAVING THE MRI ROOM, THE USER REPORTED FEELING AS IF THEY HAD BEEN PUNCHED IN THE REGION OF THE LEFT EAR. UPON ARRIVING HOME, THE USER PLACED THE AUDIO PROCESSOR AND NOTICED NO HEARING PERCEPTION ON THE LEFT SIDE. WHEN USING THE PROCESSOR ON THE RIGHT SIDE, HEARING WAS PERCEIVED NORMALLY.
Patient problems: Pain
MAUDE report 25664350 ↗MalfunctionJun 9, 2026Device Dislodged or Dislocated; Noise, Audible
ON (B)(6) 2026 THE USER'S IMPLANT SITE WAS HIT WITH SIGNIFICANT FORCE AND IN CLOSE RANGE. PAIN AROUND THE IMPLANT SITE WAS REPORTED AND IS STILL PRESENT.
Patient problems: Head Injury
MAUDE report 25443837 ↗MalfunctionApr 17, 2026Noise, Audible
AFTER THE SECOND MRI (1,5 T) THE USER IMMEDIATELY REGISTERED A CHANGE IN HEARING PERFORMANCE. THE SOUND WAS DISTORTED FROM THIS POINT ON. THE USER HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24908098 ↗MalfunctionMar 20, 2026No Device Output
THE USER WAS UNHAPPY WITH HER PERFORMANCE AS A BONEBRIDGE USER WITH SSD INDICATION. AFTER SEVERAL FITTING ATTEMPTS THE USER DECIDED TO HAVE THE DEVICE EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647140 ↗MalfunctionFeb 16, 2026Adverse Event Without Identified Device or Use Problem
THE USER WAS NO LONGER WITHIN THE INDICATION CRITERIA FOR THE DEVICE AND PREFERS USING HER CONVENTIONAL HEARING AIDS. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343760 ↗MalfunctionFeb 16, 2026No Device Output
DURING FIRST FITTING OF THE DEVICE THE USER WAS NOT ABLE TO DETECT ANY SOUND WHEN THE DEVICE WAS STIMULATED DIRECTLY. THE USER HAS BEEN RE-IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24342719 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
THE USER DEVELOPED AN INFECTED WOUND AFTER THE IMPLANTATION PROCEDURE. THE USER WAS EXPLANTED.
Patient problems: Post Operative Wound Infection
MAUDE report 24276034 ↗MalfunctionFeb 5, 2026Device Appears to Trigger Rejection
THE DEVICE IS EXPOSED THROUGH THE SKIN AT THE MAGNET/COIL. EXPLANTATION IS SCHEDULED.
Patient problems: Skin Tears
MAUDE report 24266317 ↗MalfunctionFeb 3, 2026No Device Output; Insufficient Device Problem Information
REPORTEDLY THE DEVICE MALFUNCTIONED. THE DEVICE WAS EXPLANTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24245043 ↗InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem
THE USER HAS BEEN EXPLANTED DUE TO A SKIN REACTION AND WOUND HEALING PROBLEMS POST-OPERATIVELY.
Patient problems: Post Operative Wound Infection
MAUDE report 24107237 ↗InjuryJan 2, 2026Device Appears to Trigger Rejection
THE IMPLANT IS PARTIALLY EXPOSED. EXPLANTATION IS SCHEDULED.
Patient problems: Skin Tears
MAUDE report 23941886 ↗MalfunctionDec 11, 2025No Device Output; No Device Output
PATIENT SUFFERED DOMESTIC ABUSE AND A FALL OFF THE STAIRCASE. IMPLANT STOPPED WORKING AS A RESULT OF THE BASHES TO HER HEAD. THE USER HAS BEEN RE-IMPLANTED.
Patient problems: Head Injury
MAUDE report 23778131 ↗MalfunctionDec 9, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
USER IS IN NEED OF FREQUENT MRI SO DECISION WAS TAKEN TO REIMPLANT WITH A COCHLEA IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23755140 ↗MalfunctionNov 25, 2025Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth
THE CHILD STOPPED HEARING WITH THE DEVICE AFTER IT FELL WHILE PLAYING FOOTBALL. THE USER HAS BEEN RE-IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643572 ↗InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER HAD A WOUND BREAKDOWN WITH GRANULATION AND EXPOSURE OF BCI602 POST-OPERATIVELY. THE USER HAS BEEN EXPLANTED.
Patient problems: Post Operative Wound Infection; Wound Dehiscence
MAUDE report 23508861 ↗MalfunctionNov 10, 2025No Device Output; No Device Output
HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23508860 ↗InjuryNov 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
USER CAME TO THE CLINIC WITH A VISIBLE BCI IMPLANT PROTRUDING FROM THE SKIN. USER WAS EXPLANTED.
Patient problems: Skin Tears; Tissue Breakdown
MAUDE report 23448150 ↗InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE WOUND HAS ALWAYS BEEN OOZING. CURRENTLY, THE OOZING STITCH IS OPEN, AND THE INFECTION HAS COMPROMISED THE IMPLANT.
Patient problems: Post Operative Wound Infection
MAUDE report 23425789 ↗MalfunctionOct 23, 2025No Device Output; Lack of Effect; No Device Output; Lack of Effect
NO BENEFIT WITH THE DEVICE. THE USER HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23365137 ↗
Other Active Implantable Bone Conduction Hearing System devices
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- Osia OSI300 Implant P1772248Cochlear Limited · Active implantable bone conduction hearing system837 reports
- BCI Bone Conduction Implant Kit 52180Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Active Implantable Bone Conduction Hearing System9 reports
- BCI Bone Conduction Implant Kit 51032Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implantable Bone Conduction Hearing Aid4 reports
- Sentio 186323Oticon Medical AB · Active Implantable Bone Conduction Hearing System4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.