MED-EL PULSARci100 Cochlear Implant Recalled for Leak Test Failures
MED-EL is recalling PULSARci100 Cochlear Implants because they failed helium-fine leak tests. Affected devices were distributed in the US and several international countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (implantable cochlear implant) with a manufacturing defect (leak test failure) that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
MED-EL Elektromedizinische Geräte GmbH is recalling the MED EL Cochlear Implant System, PULSARci100 Standard. The recall is due to devices being distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
The affected devices are identified by Serial Number 202001. The recall covers a quantity of 1 device. Distribution was worldwide, including the United States (specifically California and Illinois) and the following countries: Argentina, Australia, Austria, Brazil, Bulgaria, China, France, Georgia, Korea, Republic of, Poland, Russian Federation, Spain, and Sweden.
The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals. Users should contact MED-EL for further instructions regarding the recall.
The recalled product
- Product
- MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to…
- Manufacturer
- MED-EL Elektromedizinische Gereate, Gmbh
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number 202001
Distribution
Part of a larger recall action
This product is one of 3 recalled by MED-EL Elektromedizinische Gereate, Gmbh under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · MED-EL Elektromedizinische Gereate, Gmbh
See all →- HighCochlear implant devices recalled for potential internal electronics substrate defect
FDA (Devices) · 2024-07-24
- HighMED-EL SONATAti100 Cochlear Implant Recall for Leak Test Failures
FDA (Devices) · 2019-08-14
- HighMED-EL Mi1000 Cochlear Implant Recall Due to Helium Leak Test Failures
FDA (Devices) · 2019-08-14
- ModerateMED-EL SONNET Mini Battery Pack Cable Recall for Welding Defect
FDA (Devices) · 2017-03-08
Same hazard · manufacturing defect
See all →- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateAdvanced Bionics Recalls HiRes 90K Cochlear Implants Due to Loose Tools
FDA (Devices) · 2012-10-31
- ModerateMerz Recalls Prolaryn Injectable Implant Due to Incorrect Expiration Date
FDA (Devices) · 2015-12-09
- CriticalAlcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss
FDA (Devices) · 2018-10-31
- HighCochlear implant devices recalled for potential internal electronics substrate defect
FDA (Devices) · 2024-07-24
- HighMedline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers
FDA (Devices) · 2023-07-26
- HighMedtronic COBALT XT Heart Devices Recalled Due to Manufacturing Defect
FDA (Devices) · 2024-07-03