Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342 Recalls
Showing 1-5 of 5 recalls
HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal components include a stimulator (HiRes90K ICS) and electrode array (HiFocus 1j or Helix). The HiRes90K ICS is implanted surgically under the skin behind the ear. The electrode array is inserted into the cochlea. The external co
Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.
The firm, Advanced Bionics, sent a " RECALL NOTIFICATION" letter dated September 14, 2007 to all their customers who purchased the HiRes 90K devices with Helix Electrodes Model CI 1400-02H. The letter identified the product, problem, and actions to be taken. The customers were instructed to immediately locate and return the affected product to Advanced Bionics. The firm's Service representative will contact the customers within 48 hours to retrieve the affected product and send a replacement as needed. The customers were also instructed to complete and return the enclosed Notification Acknowledgement form via fax to: (661) 362-1511. If you have any questions regarding this letter, call Advanced Bionics at (877) 829-0026 between the hours of 5 AM and 5 PM Pacific Time, Monday through Friday.
OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable l6-output, multi-channel stimulator (lPO - Implantable Pulse Generator) with a rechargeable battery power
The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.
Algotec Limited initiated a Field Safety Notice Urgent Medical Device Correction letter dated April 22, 2008, with Boston Scientific forwarding a recall letter to one customer who received the recalled product. The letter instructed the consignee to replace the previously packaged manual with the OMG Connector-A manual that was supplied with the notification. The replacement of the manuals is to be confirmed via the Verification form. Customers were instructed to complete and fax the Verification Form to their local Boston Scientific Customer Service to Fax 00 44 1442 411732 by 06 May 2008. For questions regarding this recall call 661-949-4481.
Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01 Intended use: The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.
The recall action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.
Advanced Bionics (AB) Personal contacted all centers with known surgeries about the recall by telephone on November 22, 2010, and sent Blastfax to affected surgeons and clinicians. AB forwarding a Press Release on November 23, 2010 to the Business Wire News Trak. The firm also faxed Health Care Provider letters to the affected Health Care Providers and placed a Patient notification letter on the AB website on November 23, 2010. Health Care Provider letters were FedEx'ed November 24, 2010 to the affected Health Care Providers. Patient Letters were sent via FedEx'ed beginning Monday November 29th and 30th to approx. 10,500 patients. A Recall Acknowledgement Form was included for each recipient to sign as proof that the notification has been read. The press release & recall letter informed the patients/consignees of the reason for recall, the product affected and the potential hazard involved. The Health Care Provider letter also requested providers with recipient under their care who reports pain, overly loud sounds, or sudden shock sensations while the implant is powered to follow these steps: 1. Advise them to remove the external equipment immediately, 2. Schedule an appointment to complete standard troubleshooting steps listed in the AB Sound Processor User Guide, 3. If standard troubleshooting does not resolve the issue, please contact Advanced Bionics for additional troubleshooting steps that may assist in determining the presence of recall problem, 4. If your evaluation of the patient's condition suggests that the implant exhibits this problem, device explantation and replacement is advised. In addition, the Health Care Provider letter informed providers that if AB records show that you have any unregistered implants in their possession, a list of serial numbers has been provided for devices that must be returned to Advanced Bionics. If no unregistered implants have been identified, no list will be enclosed. The Patient letter also
The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-01
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.
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.
Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.
A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.
In United States, the clinician recall notification letters were distributed by Fed-Ex or U.S. Postal Service certified mail on 09/21/2006. For the other regions, the in-country representatives started providing notification to the clinicians on 09/21/2006. The recall notification letters will instruct physicians to immediately return the unimplanted units.