Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy

FDA device recall Z-0936-2007 · posted 2007-06-15 · Terminated

Recall details

Recalling firm

Zoll Lifecor Corporation

Reason for recall

The electrodes do not properly release conductive gel

Action taken

Patients currently using the product should continue to do so while the product removal is underway. Product replacements will begin with the belts currently in the possession of the sales reps. By replacing these first any new patients will be receiving new or refurbished belts with new Therapy Electrodes that have not been exposed to methanol. As patients complete their use of the LifeVest and return their device to the firm the belt's refurbishment process will include replacement of all 3 Therapy Electrodes. The firm expects this process to be completed in approximately 3 months based on the average use of time and current production capabilities. The process may take an additional month for devices distributed overseas. Physicians with active patients were notified via letter sent certified mail on 5/3/07. Long term use patients (patients using the device longer than 3 months) will be notified of the product removal via telephone and follow up letter. Each long term patient will be provided with a replacement belt. They will be instructed to return their existing belt in the same shipping box. Due to the low residual risk no notification is planned for short term use patients. Prescribing physicians have the option to notify their patients if they choose to do so.

Root cause

Other

Status

Terminated

Product code

MVK

Quantity affected

944 belts

Distribution

Worldwide: The product was shipped to patients in AZ, CA, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV. The product was also shipped t

Date initiated

2007-04-27

Date posted

2007-06-15

Date terminated

2008-03-06

Location

Pittsburgh, PA