Z-1932-2009

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

Name: Z-1932-2009 Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119...
Creator: Boston Scientific CRM Corp
Published: 2009-07-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-07-20 / Terminated / root cause: design

FDA source

Boston Scientific CRM Corp began a recall of Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100... on 2009-07-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1932-2009
Status: Terminated
Initiated: 2009-07-20
Posted: 2009-08-18
Terminated: 2012-06-26
Recalling firm: Boston Scientific Corporation
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.
Product code: LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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.

Product code LWP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)