The Recall Desk
LowFDA (Devices)·Z-0487-2021·Announced 2020-12-02

Advanced Bionics Recalls 28 Mislabelled Cochlear Implant Batteries

Advanced Bionics is recalling 28 AB PowerCel 170 batteries due to mislabeling that may indicate incorrect battery life.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is limited to mislabeling regarding battery life, with no reported injuries or illnesses.

Plain-English summary

Advanced Bionics, LLC is recalling 28 units of the AB PowerCel 170 (velvet black) battery, reference number CI-5517-150. These batteries are used to power the Naida CI Q90, Q70, and Q30 Sound Processors for cochlear implants.

The recall was initiated because it was determined that some of the batteries were improperly labeled. The labels may indicate a different battery life than the actual capacity of the device.

The affected units were distributed worldwide, including nationwide in the United States and in various international locations. Consumers with these specific batteries should contact Advanced Bionics for further instructions.

The recalled product

Product
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260). For cochlear implant.
Affected units
28

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)

  • 410078519

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Advanced Bionics, LLC 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 2 products in this recall →