Baha 93550Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BIM400 Implant Magnet · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Cochlear Baha implant magnet is a magnet used in a bone-conduction hearing system. Its 366 reports include 365 injuries and no deaths. Many describe pain, skin breakdown or overgrowth around the magnet, and infections, and some describe magnets removed or patients switched to other implant systems. 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
- 371
- Deaths reported
- 0
- Injuries reported
- 370
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 371 adverse event reports that list this exact device (DI 09321502025294), received between Oct 30, 2016 and Sep 22, 2026 — classified as 370 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (78 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
- Appropriate Device Problem Term/Code Not Available198
- Patient Device Interaction Problem78
- Adverse Event Without Identified Device or Use Problem54
- Expulsion13
- Signal Artifact/Noise10
- Insufficient Device Problem Information8
- Extrusion5
- Inadequacy of Device Shape and/or Size5
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available105
- Pain59
- No Clinical Signs, Symptoms or Conditions54
- Patient Problem/Medical Problem31
- Discomfort22
- No Code Available18
- Tissue Breakdown17
- Unspecified Infection12
Recent adverse event reports
The 25 most recent of 371 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was electively explanted on (b)(6) 2026, in order for the patient to upgrade to a newer technology. The patient was reimplanted with transcutaneous Osia Implant System.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849828 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was electively explanted on (b)(6) 2026, in order for the patient to upgrade to a newer technology. The patient was reimplanted with transcutaneous Osia Implant System.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849827 ↗InjurySep 2, 2026Expulsion; Patient Device Interaction Problem
Patient problems: Skin Infection; Tissue Breakdown
MAUDE report 50564940 ↗InjurySep 2, 2026Expulsion; Patient Device Interaction Problem
Patient problems: Skin Infection; Tissue Breakdown
MAUDE report 50564939 ↗InjuryAug 12, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced pain at implant site, even when not wearing sound processor. Subsequently, the device was explanted on (b)(6) 2026. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Implant Pain
MAUDE report 50218075 ↗InjuryJul 27, 2026Patient Device Interaction Problem
Per the clinic, the patient reportedly experienced pain at the Baha Attract magnet site and elected to undergo conversion to an Osia Implant System. Subsequently, the patient underwent revision surgery on (b)(6) 2026, in order to convert the patient to a transcutaneous Osia Implant System. During the procedure, the magnet was removed and an implant was placed on the internal fixture.
Patient problems: Implant Pain
MAUDE report 50005237 ↗InjuryMay 15, 2026Patient-Device Incompatibility; Expulsion; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN BREAKDOWN FOLLOWED BY SKIN NECROSIS DUE TO EXCESSIVE MAGNET STRENGTH. SUBSEQUENTLY, THE PATIENT DEVELOPED AN INFECTION AT THE MAGNET SITE. THE IMPLANT MAGNET WAS LATER EXPLANTED (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT REMAINS UNAVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Medical device site infection; Necrosis; Tissue Breakdown
MAUDE report 25180808 ↗InjuryMay 15, 2026Patient-Device Incompatibility; Expulsion; Appropriate Device Problem Term/Code Not Available
Per the clinic, the patient presented on (b)(6) 2026 with skin necrosis and exposure of the implant magnet. Subsequently, the patient underwent a surgical procedure including exploration, debridement and the implant magnet was explanted on (b)(6) 2026.
Patient problems: Medical device site infection; Necrosis; Tissue Breakdown
MAUDE report 25180807 ↗InjuryMay 15, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2026, AND THE INTERNAL MAGNET WAS EXPLANTED TO CONVERT THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM. DURING THE PROCEDURE, THE MAGNET WAS REMOVED AND THE IMPLANT WAS REIMPLANTED ON A DIFFERENT SITE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25180268 ↗InjuryMay 14, 2026Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED PERFORMANCE DECREMENT WITH THEIR BAHA ATTRACT SYSTEM. AFTER EVALUATION, THE IMPLANT MAGNET WAS EXPLANTED ON (B)(6) 2025 UNDER GENERAL ANESTHESIA, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY FOR BETTER PERFORMANCE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25179448 ↗InjuryMay 14, 2026Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED PERFORMANCE DECREMENT WITH THEIR BAHA ATTRACT SYSTEM. AFTER EVALUATION, THE IMPLANT MAGNET WAS EXPLANTED ON (B)(6) 2025 UNDER GENERAL ANESTHESIA, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY FOR BETTER PERFORMANCE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25179447 ↗InjuryMay 14, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED PERSISTENT PAIN IN THE MAGNET SITE. SUBSEQUENTLY, THE INTERNAL MAGNET WAS EXPLANTED ON (B)(6) 2026 AND IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Implant Pain
MAUDE report 25168593 ↗InjuryMay 13, 2026Patient Device Interaction Problem
PER THE CLINIC, THE IMPLANT MAGNET WAS EXPLANTED ON (B)(6) 2026 DUE TO PATIENT EXPERIENCING PAIN AND SHE STOPPED USING THE DEVICE.
Patient problems: Implant Pain
MAUDE report 25157184 ↗InjuryMay 13, 2026Patient Device Interaction Problem
PER THE CLINIC, THE IMPLANT MAGNET WAS EXPLANTED ON (B)(6) 2026 DUE TO PATIENT EXPERIENCING PAIN AND SHE STOPPED USING THE DEVICE.
Patient problems: Implant Pain
MAUDE report 25157183 ↗InjuryApr 14, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SWELLING AND INFECTION AROUND THE MAGNET SITE. SUBSEQUENTLY, PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2026, IN ORDER TO CONVERT THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM ON A DIFFERENT SITE. DURING THE PROCEDURE, THE INTERNAL MAGNET WAS REMOVED.
Patient problems: Skin Infection; Swelling/ Edema
MAUDE report 24880147 ↗InjuryApr 7, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE IMPLANT MAGNET WAS EXPLANTED ON (B)(6) 2026, DUE TO LACK OF BENEFIT DUE TO POOR HIGH FREQUENCY ACCESS. SUBSEQUENTLY, THE PATIENT WAS CONVERTED TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM UNDER GENERAL ANESTHESIA DURING THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24796513 ↗InjuryApr 7, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE IMPLANT MAGNET WAS EXPLANTED ON (B)(6) 2026, DUE TO LACK OF BENEFIT DUE TO POOR HIGH FREQUENCY ACCESS. SUBSEQUENTLY, THE PATIENT WAS CONVERTED TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM UNDER GENERAL ANESTHESIA DURING THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24796511 ↗InjuryMar 11, 2026Inadequacy of Device Shape and/or Size
PER THE CLINIC, THE PATIENT EXPERIENCED RETENTION ISSUE DUE TO A THICK SKIN FLAP. SUBSEQUENTLY, THE PATIENT IMPLANT MAGNET HAS BEEN EXPLANTED ON (B)(6) 2026 UNDER GENERAL ANAESTHESIA. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24566152 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE DEVICE WAS EXPLANTED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, IN ORDER TO CONVERT THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM FOR SYSTEM UPGRADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24554710 ↗InjuryFeb 25, 2026Signal Artifact/Noise; Inadequacy of Device Shape and/or Size
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AT THE MAGNET SITE. THE PATIENT WORE A SOFT PAD TO ACHIEVE ADEQUATE RETENTION; HOWEVER, THE PATIENT CONTINUED TO EXPERIENCE DISCOMFORT AND PAIN DUE TO THE TIGHTNESS AND STRENGTH OF THE MAGNET CONNECTION TO THE IMPLANT. A REDUCED-STRENGTH MAGNET DID NOT PROVIDE ADEQUATE RETENTION. DUE TO THE PAIN, THE PATIENT WAS UNABLE TO WEAR THE PROCESSOR FOR EXTENDED PERIODS OF TIME. THE PATIENT ALSO REPORTED DISCOMFORT WITH SOUND QUALITY IN NOISY ENVIRONMENTS AND EXCESSIVE ACOUSTIC FEEDBACK FROM THE PROCESSOR. SUBSEQUENTLY, THE INTERNAL MAGNET WAS EXPLANTED UNDER GENERAL ANESTHESIA ON (B)(6) 2026 AND THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Discomfort; Pain
MAUDE report 24442062 ↗InjuryFeb 25, 2026Signal Artifact/Noise; Inadequacy of Device Shape and/or Size
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AT THE MAGNET SITE. THE PATIENT WORE A SOFT PAD TO ACHIEVE ADEQUATE RETENTION; HOWEVER, THE PATIENT CONTINUED TO EXPERIENCE DISCOMFORT AND PAIN DUE TO THE TIGHTNESS AND STRENGTH OF THE MAGNET CONNECTION TO THE IMPLANT. A REDUCED-STRENGTH MAGNET DID NOT PROVIDE ADEQUATE RETENTION. DUE TO THE PAIN, THE PATIENT WAS UNABLE TO WEAR THE PROCESSOR FOR EXTENDED PERIODS OF TIME. THE PATIENT ALSO REPORTED DISCOMFORT WITH SOUND QUALITY IN NOISY ENVIRONMENTS AND EXCESSIVE ACOUSTIC FEEDBACK FROM THE PROCESSOR. SUBSEQUENTLY, THE INTERNAL MAGNET WAS EXPLANTED UNDER GENERAL ANESTHESIA ON (B)(6) 2026 AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Discomfort; Pain
MAUDE report 24442060 ↗InjuryFeb 19, 2026Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE IMPLANT MAGNET WAS EXPLANTED ON (B)(6) 2026 UNDER GENERAL ANESTHESIA, AS THE PATIENT WANTS INCREASED HEARING GAIN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24385728 ↗InjuryJan 22, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT AND LIMITED BENEFIT RESULTING IN THE DECISION TO DISCONTINUE USE OF THE DEVICE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, IN ORDER TO EXPLANT THE INTERNAL MAGNET AND TO TRANSITION THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM ON A NEW INTERNAL FIXTURE WITHIN THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24141993 ↗InjuryJan 22, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT AND LIMITED BENEFIT RESULTING IN THE DECISION TO DISCONTINUE USE OF THE DEVICE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, IN ORDER TO EXPLANT THE INTERNAL MAGNET AND TO TRANSITION THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM ON A NEW INTERNAL FIXTURE WITHIN THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24141992 ↗InjuryJan 16, 2026Signal Artifact/Noise
PER THE CLINIC, THE PATIENT EXPERIENCED FEEDBACK NOISE. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, IN ORDER TO REMOVE THE INTERNAL MAGNET AND TO TRANSITION THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM FOR BETTER SOUND QUALITY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24091020 ↗
Other Hearing aid, bone conduction, implanted devices
- Baha 93331Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted446 reports
- Baha 93332Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted376 reports
- Baha 93330Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted269 reports
- Baha 93338Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted128 reports
- Ponto M52169Oticon Medical AB · Hearing Aid, Bone Conduction, Implanted124 reports
- Ponto M52170Oticon Medical AB · Hearing Aid, Bone Conduction, Implanted120 reports
- Baha 93335Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted81 reports
- Baha 93334Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted61 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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