Boston Scientific CRM Corp: FDA recalls

FDA enforcement reports name Boston Scientific CRM Corp as the recalling firm in 6 events. The events have 8 product records. The recalls started from 2013 to 2014. All the events are device recalls.

See the 6 events

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 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

6 events, newest first.

FDA enforcement events of Boston Scientific CRM Corp
Initiated	Product (first record)	Type	Class	Records	Status
17 Sep 2014	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…	Device	Class II	2	Terminated
19 Jun 2014	Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.	Device	Class II	1	Terminated
29 Aug 2013	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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who…	Device	Class II	2	Terminated
15 Jul 2013	Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.	Device	Class II	1	Terminated
10 Apr 2013	LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.	Device	Class II	1	Terminated
1 Mar 2013	Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Boston Scientific CRM Corp: events for each product type
Type		Events
Device		6

Boston Scientific CRM Corp: events in each class
Class		Events
Class II		6

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

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.

Events by year

FDA enforcement events of Boston Scientific CRM Corp, by the year that the recall started. The largest year is 2013, with 4 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Boston Scientific CRM Corp: FDA recalls. https://recallregister.com/firm/boston-scientific-crm-corp/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: MN

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Boston Scientific CRM Corp have?: Class II: 6 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Boston Scientific CRM Corp?: FDA event 69291, which the firm started on 17 Sep 2014. The first product in the record is: 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…
How many FDA recalls of Boston Scientific CRM Corp have the status Ongoing?: No event has the status Ongoing in the openFDA file. openFDA says 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.