St. Jude Medical, Cardiac Rhythm Management Division: FDA recalls

FDA enforcement reports name St. Jude Medical, Cardiac Rhythm Management Division as the recalling firm in 9 events. The events have 14 product records. The recalls started from 2014 to 2022. All the events are device recalls.

See the 9 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

9 events, newest first.

FDA enforcement events of St. Jude Medical, Cardiac Rhythm Management Division
Initiated	Product (first record)	Type	Class	Records	Status
17 Jun 2022	Merlin PCS 3650 programmer Model 3330 software	Device	Class II	3	Ongoing
10 Mar 2022	Merlin PCS 3650 programmer Model 3330 software	Device	Class II	2	Ongoing
10 Mar 2022	Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q	Device	Class II	3	Ongoing
22 Jan 2020	Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330	Device	Class II	1	Terminated
13 Apr 2018	Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect…	Device	Class II	1	Terminated
3 Nov 2015	Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).	Device	Class I	1	Terminated
18 Aug 2015	Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.	Device	Class II	1	Terminated
18 Dec 2014	Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter	Device	Class II	1	Terminated
19 Aug 2014	Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.	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

St. Jude Medical, Cardiac Rhythm Management Division: events for each product type
Type		Events
Device		9

St. Jude Medical, Cardiac Rhythm Management Division: events in each class
Class		Events
Class II		8
Class I		1

Share of the events of the firm in Class I: 11%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 3

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 St. Jude Medical, Cardiac Rhythm Management Division, by the year that the recall started. The largest year is 2022, with 3 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. St. Jude Medical, Cardiac Rhythm Management Division: FDA recalls. https://recallregister.com/firm/st-jude-medical-cardiac-rhythm-management-division/. 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: CA

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 St. Jude Medical, Cardiac Rhythm Management Division have?: Class II: 8 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of St. Jude Medical, Cardiac Rhythm Management Division?: FDA event 90530, which the firm started on 17 Jun 2022. The first product in the record is: Merlin PCS 3650 programmer Model 3330 software
How many FDA recalls of St. Jude Medical, Cardiac Rhythm Management Division have the status Ongoing?: 3 events have 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.