Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17381 |
| Brand Name: | Boston Scientific COGNIS ICD Models N106, P106 |
| Model: | Models: N106 & P106 |
| Affected: | Manufactured prior to March 2010 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cardiac Pacemakers Inc |
| Brand Name: | Boston Scientific COGNIS ICD Models N107, P107 |
| Model: | Models: N107, P107 |
| Affected: | Manufactured prior to March 2010 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cardiac Pacemakers Inc |
| Brand Name: | Boston Scientific TELIGEN ICD Models E110 & F110 |
| Model: | Models: E110 & F110 |
| Affected: | Manufactured prior to March 2010 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cardiac Pacemakers Inc |
| Brand Name: | Boston Scientific TELIGEN ICD Models E102 & F102 |
| Model: | Models: E102 & F102 |
| Affected: | Manufactured prior to March 2010 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cardiac Pacemakers Inc |
| Brand Name: | Boston Scientific COGNIS ICD Models N108, P108 |
| Model: | Models: N108 & P108 |
| Affected: | Manufactured prior to March 2010 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cardiac Pacemakers Inc |
| Brand Name: | Boston Scientific TELIGEN ICD Models E111 & F111 |
| Model: | Models: E111 & F111 |
| Affected: | Manufactured prior to March 2010 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cardiac Pacemakers Inc |
| Brand Name: | Boston Scientific TELIGEN ICD Models E103, F103 |
| Model: | Models: E103 & F103 |
| Affected: | Manufactured prior to March 2010 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cardiac Pacemakers Inc |
| Issue: | A subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. With one additional year of clinical experience and analysis, the manufacturer has identified a second subset of devices that may exhibit compromised LV capacitor performance at a rate that is similar to the August 2013 advisory subset. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 18/9/2014 |
