Advanced Bionics recalled its HiRes 90K Cochlear Implant device, Model CI-1400-01, in a Class 2 voluntary action the FDA posted December 21, 2010. The company began retrieving 332 unimplanted units nationwide on November 23, 2010, after two malfunction reports.
Recipients in those reports felt severe pain, loud sounds, or shocking sensations 8 to 10 days after activation and needed the device removed. Advanced Bionics told providers to remove external equipment, troubleshoot, and replace confirmed devices.
Owners of an already-implanted HiRes 90K device did not need to act, since the recall covered only unimplanted units. The FDA lists the recall as terminated, closed March 23, 2012, after Advanced Bionics finished the retrieval.
- Action type: Class 2 voluntary recall (unimplanted units)
- Announcement and initiation dates: Initiated November 23, 2010; posted December 21, 2010; terminated March 23, 2012
- Company and responsible agency: Advanced Bionics Corporation (Sylmar, CA) / FDA (recall record)
- Recall or campaign number: Z-0795-2011
- Affected models, lots, UPCs, serial numbers, or VINs: HiRes 90K Cochlear Implant device, Model CI-1400-01 (unimplanted units only)
- Number of affected units: 332 units in commerce, nationwide (36 states)
- Sold at and sale period: Not a retail sale – distributed to implant centers/surgeons nationwide; no price stated
- Hazard: Malfunction requiring explantation: severe pain, loud sounds, or shocking sensations 8-10 days after activation
- Reported incidents, injuries, illnesses, and deaths: Two confirmed malfunction/explantation reports as of Nov 2010
- Remedy: Advanced Bionics retrieved unimplanted inventory; symptomatic recipients: remove external equipment, troubleshoot, contact Advanced Bionics, explant/replace if confirmed
Table Of Contents
- Latest Cochlear Ear Implants Recall Updates
- December 20, 2022: DOJ Settles False Claims Act Case over Processor Testing
- March 10, 2020: FDA Posts Advanced Bionics’ HiRes Ultra Corrective Action
- April 16, 2013: Jury Awards $7.25 Million to the Sadler Family
- July 10, 2012: FDA Terminates the Cochlear Nucleus CI512 Recall
- March 23, 2012: FDA Terminates the HiRes 90K Recall
- October 3, 2011: FDA Posts the Cochlear Nucleus CI512 Recall
- December 21, 2010: FDA Posts Advanced Bionics’ Second HiRes 90K Recall
- July 18, 2008: FDA Announces $1.1 Million Settlement over 2006 Recall
- September 24, 2004: Boston Scientific Recalls CLARION and HiResolution Implants Worldwide
- Which Cochlear Ear Implants Are Affected?
- Why Were Cochlear Ear Implants Recalled?
- Reported Incidents, Injuries, or Illnesses
- What Should Consumers Do?
- Other Recalls, Warnings, or International Actions
- Legal Options
- Filing Deadlines
- Frequently Asked Questions
- What Are the Signs a Cochlear Implant Is Failing?
- What Is a Class 2 Recall?
- What Happened in the Kentucky Cochlear Implant Lawsuit?
- What Risks Does the FDA Warn About for Cochlear Implants?
- What Types of Cochlear Implant Problems Lead to Lawsuits?
- Who Filed the Whistleblower Case Behind the 2022 Settlement?
- References
Latest Cochlear Ear Implants Recall Updates
December 20, 2022: DOJ Settles False Claims Act Case over Processor Testing
The Justice Department announced that Advanced Bionics agreed to pay $11.36 million, plus $1,238,580 to Medicaid programs [1]. The settlement resolved allegations the company gave the FDA false radio-frequency test results for its Neptune and Naida processors.
The settlement resolved a whistleblower lawsuit under the False Claims Act, case No. 19-cv-3439 in the Eastern District of Pennsylvania. Advanced Bionics admitted no liability under the agreement.
March 10, 2020: FDA Posts Advanced Bionics’ HiRes Ultra Corrective Action
The FDA published a voluntary field corrective action Advanced Bionics issued for its HiRes Ultra and Ultra 3D cochlear implants, citing fluid ingress at the electrode and hearing-performance degradation [2].
Of more than 16,000 recipients worldwide, fewer than 0.5% had been explanted for the issue as of February 11, 2020. Existing recipients could keep using their device and were told to see a provider if performance declined.
April 16, 2013: Jury Awards $7.25 Million to the Sadler Family
A federal jury in the U.S. District Court for the Western District of Kentucky awarded the Sadlers $7.25 million, finding the HiRes 90K device negligently designed, defective, and unreasonably dangerous [3].
A leaking device had shocked their daughter three times and required an eight-hour surgery to replace it. The case was the first of about 40 lawsuits nationally to reach trial. Advanced Bionics disagreed with the verdict and considered appealing.
July 10, 2012: FDA Terminates the Cochlear Nucleus CI512 Recall
The FDA closed the Cochlear Nucleus CI512 recall (Z-0003-2012), which had covered 33,645 units worldwide after the company found a component that could make the implant shut down [4].
About 25,516 of the recalled units worldwide had already been implanted when the recall began in September 2011, with the remaining 1,741 units still available in the U.S. market for future surgeries.
March 23, 2012: FDA Terminates the HiRes 90K Recall
The FDA closed the Z-0795-2011 recall that Advanced Bionics had opened in November 2010. The recall covered 332 unimplanted HiRes 90K units distributed to centers in 36 states, after two confirmed malfunction reports.
Advanced Bionics had finished retrieving the affected inventory and completing provider notifications to health care providers nationwide, meeting the FDA’s conditions for closing the recall about eighteen months after it began.
October 3, 2011: FDA Posts the Cochlear Nucleus CI512 Recall
The FDA posted a Class 2 recall for the Cochlear Nucleus CI512 implant, initiated September 16, 2011, over a design issue that risked the device shutting down and losing function unexpectedly.
The action covered 33,645 units distributed worldwide, including implant centers across the United States, Europe, and Australia. Cochlear told surgeons to counsel patients about the shutdown risk and follow its monitoring guidance.
December 21, 2010: FDA Posts Advanced Bionics’ Second HiRes 90K Recall
The FDA posted Advanced Bionics’ second HiRes 90K recall, initiated November 23, 2010, retrieving 332 unimplanted units nationwide after two confirmed malfunction reports.
The company’s press release told providers with symptomatic patients to remove external equipment, run standard troubleshooting, contact Advanced Bionics if the problem continued, and explant and replace confirmed devices [5].
July 18, 2008: FDA Announces $1.1 Million Settlement over 2006 Recall
The FDA announced a $1.1 million settlement with Advanced Bionics, plus $75,000 from then-CEO Jeffrey Greiner [6]. The penalty followed the company’s failure to notify the agency of a component-supplier change behind its March 2006 HiRes 90K recall.
That March 2006 action had recalled unimplanted HiRes 90K devices for the same unapproved component. The FDA alleged that in at least two cases, a device with the component was implanted in a patient after the recall began.
September 24, 2004: Boston Scientific Recalls CLARION and HiResolution Implants Worldwide
Boston Scientific, which had acquired Advanced Bionics that June, announced a worldwide recall of about 440 unimplanted CLARION and HiResolution implants [7]. The recall cited possible moisture in the internal circuitry that could stop the device working.
The recall did not affect already-implanted patients, and the company said it was not aware of any related patient injuries at the time.
Which Cochlear Ear Implants Are Affected?
The best-documented cochlear implant recall in this device category covered unimplanted Advanced Bionics units. Providers and patients can check any device on hand against these identifiers:
- HiRes 90K device (Advanced Bionics, Model CI-1400-01), unimplanted units only, recall number Z-0795-2011
- Distributed to implant centers and surgeons across 36 states, including AL, CA, FL, NY, and TX. The FDA classified the action a Class 2 voluntary recall.
Other cochlear implant brands have separately been recalled, including the Cochlear Nucleus CI512, Advanced Bionics HiRes Ultra/Ultra 3D, and Advanced Bionics’ earlier CLARION and HiResolution implants. Each is detailed below in Other Recalls, Warnings, or International Actions.
Why Were Cochlear Ear Implants Recalled?
Advanced Bionics recalled the HiRes 90K after two recipients needed it explanted for a malfunction that caused the pain, loud sounds, and shocking sensations described above, within 8 to 10 days of activation.
Advanced Bionics said it was evaluating the root cause and working with the FDA to improve the HiRes 90K’s quality under recall Z-0795-2011. Already-implanted devices were not part of the retrieval.
The recall followed two earlier Advanced Bionics moisture problems: a 2004 CLARION and HiResolution recall, and a March 2006 HiRes 90K recall over an unapproved supplier’s component. That 2006 recall led to the 2008 FDA settlement over the nondisclosure.
Reported Incidents, Injuries, or Illnesses
The FDA’s recall record for the HiRes 90K device lists two malfunction reports requiring explantation as of the November 2010 notice. Both recipients felt intense pain and a sudden electrical shock 8 to 10 days after activation.
A federal jury separately awarded $7.25 million in the Sadler family’s injury claim over a leaking HiRes 90K device (the April 16, 2013 update above has the full verdict).
These reports describe what regulators and courts recorded. They are not proof the device caused every malfunction or the Sadler injury. Neither the HiRes 90K recall record nor the Cochlear Nucleus CI512 recall record lists a death.
What Should Consumers Do?
Anyone with an Advanced Bionics HiRes 90K device, or caring for someone who has one, should take these steps if pain, loud sounds, or a shocking sensation appears:
- Remove the external sound processor right away if the recipient feels pain, an unusually loud sound, or a shock while the implant is powered on.
- Complete the standard troubleshooting steps in the Advanced Bionics Sound Processor User Guide.
- Contact Advanced Bionics for further troubleshooting if the problem does not resolve.
- See the implant surgeon or audiologist for evaluation. Explantation and replacement is advised if the malfunction is confirmed.
- Report the problem to the FDA’s MedWatch program online at www.fda.gov/MedWatch/report.htm or by calling 1-800-332-1088.
Other Recalls, Warnings, or International Actions
Other cochlear implant makers have had separate FDA actions. The Cochlear Nucleus CI512 (Z-0003-2012) was recalled worldwide for a shutdown-risk component, and HiRes Ultra/Ultra 3D had a March 2020 corrective action for fluid ingress and hearing decline.
In 2004, Boston Scientific, then Advanced Bionics’ parent, recalled unimplanted CLARION and HiResolution implants worldwide for a similar moisture problem.
Legal Options
Product-liability lawsuits over HiRes 90K-type malfunctions have proceeded case by case rather than as a class action. Sadler v. Advanced Bionics reached trial first among about 40 individual lawsuits nationally, resulting in the $7.25 million verdict above.
Advanced Bionics separately settled a December 2022 DOJ case for $11.36 million over unrelated processor test data. The JPML‘s pending-MDL list carries no cochlear-implant entry, so no MDL has formed [8].
A recall does not automatically establish liability or eligibility for compensation. An Advanced Bionics cochlear implant lawsuit review can look at individual circumstances.
Filing Deadlines
Filing deadlines for a product-liability claim come from state law rather than a federal recall notice. They vary by where the reader lives and when the injury or diagnosis happened, and some states start the clock at diagnosis instead.
Missing the applicable deadline can end a claim even when the underlying facts are strong, so anyone considering a claim should check with a lawyer promptly.
Frequently Asked Questions
What Are the Signs a Cochlear Implant Is Failing?
Signs a cochlear implant may be failing include the pain, loud sounds, or shocking sensations named in the recall record. A MAUDE-database study of implant reports also found common complications: device failure, fluid buildup, infection, or skin problems near the implant.
What Is a Class 2 Recall?
A Class 2 recall, the classification given to the HiRes 90K action described above, is the FDA’s term for a situation where serious harm is unlikely, though temporary or reversible injury is possible. A Class 1 recall, reserved for a reasonable probability of serious injury or death, is more severe.
What Happened in the Kentucky Cochlear Implant Lawsuit?
The Kentucky cochlear implant lawsuit was Sadler v. Advanced Bionics, where a federal jury in Louisville ruled for an 11-year-old girl, Breanna Sadler, and her parents. The verdict amount is detailed in the April 16, 2013 update above. Advanced Bionics disputed the ruling and considered an appeal.
What Risks Does the FDA Warn About for Cochlear Implants?
The FDA warns that cochlear implants carry a rare but serious risk of meningitis, an infection of the lining of the brain’s surface. People with abnormally formed inner-ear structures face a greater risk. This risk is separate from the malfunction hazard behind the HiRes 90K recall.
What Types of Cochlear Implant Problems Lead to Lawsuits?
Cochlear implant problems that have led to lawsuits include device malfunctions causing shock or severe pain, and hearing-performance decline from fluid ingress. Some claims, as in the Sadler case, allege a manufacturer kept selling a device after learning it was defective.
Who Filed the Whistleblower Case Behind the 2022 Settlement?
A former Advanced Bionics engineer named David Nyberg filed the whistleblower lawsuit behind the 2022 settlement under the False Claims Act. He was set to receive about $1.87 million of the $11.36 million the government recovered.
References
- https://www.oversight.gov/advanced-bionics-llc-pay-united-states-1136-million-resolve-fca-allegations-related-cochlear
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-field-corrective-action-hires-ultra-and-ultra-3d
- https://www.usatoday.com/story/news/nation/2013/04/18/cochlear-implant-case-award/2094397/
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104183
- https://www.einpresswire.com/article/56770233/hires-90k-cochlear-implant-device-recall-malfunction
- https://www.mddionline.com/regulatory-quality/advanced-bionics-reaches-1-1-million-settlement-with-fda
- https://news.bostonscientific.com/news-releases?item=58646
- https://www.jpml.uscourts.gov/pending-mdls-0