Device recall: Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following…
Class II FDA enforcement event 69291. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Boston Scientific identified 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. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Boston Scientific CRM Corp started this device recall on 17 Sep 2014. The firm address in the FDA record is in Saint Paul, MN. FDA put the recall in Class II. FDA event 69291 has 2 product records. The first FDA enforcement report date is 29 Oct 2014. The record gives the status Terminated, with the termination date 20 Feb 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico, and U.S. - Virgin Islands. OUS countries to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados,…
Recalling firm
Boston Scientific CRM Corp, Saint Paul, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0087-2015 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated… | 31,144 total | Class II | Terminated | 29 Oct 2014 |
| Z-0088-2015 | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies… | 31,144 devices total | Class II | Terminated | 29 Oct 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Jun 2014 | Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: T | Device | Class II | 1 |
| 29 Aug 2013 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models | Device | Class II | 2 |
| 15 Jul 2013 | Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator. | Device | Class II | 1 |
| 10 Apr 2013 | LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use | Device | Class II | 1 |
| 1 Mar 2013 | Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0087-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 69291. https://recallregister.com/fda/ii/69291/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico, and U.S. - Virgin Islands. OUS countries to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados,…
- What quantity of product is in FDA event 69291?
- The event has 2 product records. The first record gives this quantity:
31,144 total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.