Skip to content

HR90K Platinum Series Headpiece Model Number AB-7300-001… recallZ-0956-2009 · Advanced Bionics LLC · initiated Jul 24, 2008

Terminated All recalls posted in February 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Advanced Bionics LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cann

FDA root cause category: Employee error

What the company is doing

Advanced Bionics is notifying clinicians of this situation so that they can provide appropriate clinical management. The notification letter sent to clinicians in the United States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are not affected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Since discovery of this issue firm has conducted an extensive technical analysis showing that the use of these headpieces does not pose any safety risk to the patient. While there has been no increase in the number of headpiece-related complaints, firm advises of the potential clinical symptoms: -No lock -Intermittent lock -Implant locks, but cannot measure impedances -Reduction in battery life, primarily for C1 patients with thick flaps. Per the letter, as long as the system maintains lock, there is no degradation in sound quality or stimulation. Further, the impact on battery life for CII and HiRes 90K patients is minimal. Medical professionals are advised that If they have any patients who display any of these clinical symptoms that they attribute to an affected headpiece, to advise the patient to contact Advanced Bionics Customer Service at 877-244-9541 and they will send them a replacement promptly.

Recall details

Recall number
Z-0956-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 24, 2008
Posted by the FDA
Feb 3, 2009
Recalling firm
Advanced Bionics LLC
Quantity
2,049 units
Product code
MCM
FDA submissions
P960058
Distribution
Nationwide

Product description

HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The HiRes90K headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.

Code information (models, lots, serial numbers)

Model #AB-7300-001; Serial Numbers: 167419, 167420, 169309, 169310, 169311, 170983, 170984, 170985, 172709, 172710, 174272, 174274, 174275, 174298, 175139, 175988, 175989, 175990, 175991, 177627, 177628, 177629, 177630, 177631, 177671, 177672, 177673, 178494, 179252, 181303, 181304, 183489, 184405 and 184694

Other devices under the same FDA submission

25 devices cleared under P960058 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 50204).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page