The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1395-2017·Announced 2017-03-08

MED-EL SONNET Mini Battery Pack Cable Recall for Welding Defect

MED-EL is recalling 538 SONNET Mini Battery Pack Cables because the compartment lock was not firmly welded to the housing.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect is a manufacturing issue (welding) without reported injuries or illnesses, fitting the Moderate severity criteria for a precautionary recall of a medical device component.

Plain-English summary

MED-EL Elektromedizinische Gereate, Gmbh is recalling 538 units of the SONNET Mini Battery Pack Cable. This cable is part of the SONNET Mini Battery Pack, an external battery pack used to power one MED-EL SONNET control unit. The cable connects the battery pack to the processor unit and can be worn on the upper body or hip.

The recall was initiated after firm inspection revealed that the units did not have the compartment lock firmly welded to the housing. This defect affects the structural integrity of the battery pack's compartment lock.

The affected products were distributed worldwide, including in the United States (California, North Carolina, and Texas) and in Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay. Specific part numbers and kit UDI codes are listed in the agency's recall record. Consumers with these devices should contact MED-EL for instructions on how to proceed.

The recalled product

Product
SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini…
Manufacturer
MED-EL Elektromedizinische Gereate, Gmbh
Category
Medical Device — Hearing Aid Accessories
Hazard
Affected units
538

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 (17)

  • Part No. 32291
  • Kit 33372
  • Kit UDI - Primary ID: 09008737333720 (anthracite 50)
  • Part No. 32292
  • Kit 33374
  • Kit UDI - Primary ID: 09008737333744 (ebony 50)
  • Part No. 32293
  • Kit 33375
  • Kit UDI - Primary ID: 09008737333751 (black 50)
  • Part No. 32294
  • Kit 33376
  • Kit UDI - Primary ID: 09008737333768 (white 50)
  • Part No. 32295
  • Kit 33377
  • Kit UDI - Primary ID: 09008737333775 (beige 50) and Part No. 32296
  • Kit 33378
  • Kit UDI - Primary ID: 09008737333782 (grey 50).

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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