Advanced Bionics Corporation: The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-02H.

Recall number

Z-0759-06

Recalling firm

Advanced Bionics Corporation

Product

The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-02H.

Status

Terminated

Initiated

2006-03-08

Posted

2006-04-11

Terminated

2012-03-23

Reason

Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.

Root cause

Other

Action

The recall was initiated on 03/08/06. In North America, the clinician notification letters were distributed by fax. For other regions, an Advanced Bionics representative and/or distributor are providing notification to the affected clinicians. As part of the clinician notification process, each center was provided with a list of their affected devices. Customers were given a list of HiRes 90K implants with feedthrus from Supplier B that were shipped to their clinic and are not yet registered with Advanced Bionics. Customers were asked to return the implants listed in the attachment to Advanced Bionics according to the instructions. Customers were told not to implant any of the devices on the list. Customers were told that implants manufactured wth feedthrus from Supplier A will be delivered quickly to minimize disruptions to their schedule. Customers will be contacted through Advanced Bionics Customer Service within 48 hours to arrange retrieval of implants manufactured with feedthrus from Supplier B and replacement with implants manufactured with feedthrus from Supplier A.

Quantity

613 units for both models (186 in the U.S.), (427 ROW)

Distribution

Nationwide to: AR, AL, FL, TX, NY, NE, NC, CO, GA, OH, IL, PA, IN, MN, NC, CA, HI, MA, AZ, VA, OR, SD, MI, MO, IA, UT, TN. Worldwide to: Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cuba, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Venezuela.

Lot, serial or model codes

Model CI-1400-02H. Serial numbers: 350550, 350974, 350386, 350613, 350654, 350687, 350714, 350754, 350859, 350964, 350998, 351006, 351031, 351035, 351063, 351129, 351132, 351139, 350568, 350121, 350486, 350514, 350581, 350655, 350896, 350955, 350958, 350967, 350452, 350816, 350949, 350959, 350963, 351021, 351140, 350489, 350492, 350505, 350555, 350789, 350910, 250914, 350957, 351036, 350565, 351020, 350251, 350283, 350482, 350509, 350519, 350524, 350525, 350527, 350531, 350532, 350583, 350676, 350689, 351046, 350535, 350220, 350224, 350239, 350246, 350250, 350254, 350256, 350260, 350294, 351069.

510(k) numbers

not on file

PMA numbers

["P960058"]

Product code

MCM

Firm FEI

1000220815

Firm city

Sylmar

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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