Boston Scientific CRM Corp Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.
Brand
Boston Scientific CRM Corp
Lot Codes / Batch Numbers
Model N118, Serial numbers: 559134, 559655, 560551, 561872, 561997, 562290, 562354, 562357, 563022, 563129, 564231, 564257, 564276 and 564489 and Model N119, Serial numbers: 002009, 005588, 005947, 006015, 008336, 008383, 011748, 016012, 016410, 018621, 019026, 019284, 024632, 024670, 024705, 025094, 025446, 026128, 026211, 026713, 026935, 028047, 032967, 033881, 035717, 035791, 035824, 037277, 044056, 046565 and 046574.
Products Sold
Model N118, Serial numbers: 559134, 559655, 560551, 561872, 561997, 562290, 562354, 562357, 563022, 563129, 564231, 564257, 564276 and 564489 and Model N119, Serial numbers: 002009, 005588, 005947, 006015, 008336, 008383, 011748, 016012, 016410, 018621, 019026, 019284, 024632, 024670, 024705, 025094, 025446, 026128, 026211, 026713, 026935, 028047, 032967, 033881, 035717, 035791, 035824, 037277, 044056, 046565 and 046574.
Boston Scientific CRM Corp is recalling Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N11 due to Boston Scientific Cardiac Rhythm Management retrieved devices that could be subject to a potential for acute non-secure lead connections when implante. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CT, FL, GA, IL, IA, KY, MD, MO, NH, NJ, NY, OH, PA, SC, TN, TX, WA, WI, PR
Page updated: Jan 10, 2026