Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using

FDA device recall Z-1932-2009 · posted 2009-08-18 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

Reason for recall

Boston Scientific Cardiac Rhythm Management retrieved devices that could be subject to a potential for acute non-secure lead connections when implanted. Nonsecure lead connections can manifest as high impedance, or lead electrogram artifacts resulting in oversensing and/or inappropriate delivery of therapy.

Action taken

Boston Scientific Corporation field personnel began retrieving devices containing the original set screw system on Friday, July 17, 2009. If needed a letter, dated 07/17/2009 was left with the hospital administrator letting them know that product has been collected for return to Boston Scientific Corporation. Replacement devices will be provided at no charge. If the field personnel was unable to contact the hospital in the time provided, a notification letter dated July 22, 2009 was sent via Federal Express to the hospital. This letter was directed to the EP Catheter Lab Manager with a cc to the Hospital Risk Manager, Hospital Administrator and Purchasing and Central Supply. The letter asked that the affected devices not be implanted and to contact their local representative for pick-up and return. The firm will replace the affected devices. Please direct questions to your local Sales representative or Boston Scientific Corporation CRM Technical Services by calling 1-800-227-3422.

Root cause

Device Design

Status

Terminated

Product code

LWP

Quantity affected

45

Distribution

U.S. Distribution only (states of AZ, CA, CT, FL, GA, IA, IL, KY, MD, MO, NH, NJ, NY, OH, PA, SC, TN, TX, WI, and Washington D.C.) and Puerto Rico.

Date initiated

2009-07-20

Date posted

2009-08-18

Date terminated

2012-06-26

Location

Saint Paul, MN