Device recall: Merlin PCS 3650 programmer Model 3330 software

Class II FDA enforcement event 89816. Recall start date: 10 Mar 2022. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.

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

St. Jude Medical, Cardiac Rhythm Management Division started this device recall on 10 Mar 2022. The firm address in the FDA record is in Sylmar, CA. FDA put the recall in Class II. FDA event 89816 has 2 product records. The first FDA enforcement report date is 27 Apr 2022. The record gives the status Ongoing.

FDA enforcement report The 2 product records

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.

Distribution

In the words of FDA.

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY,…

Recalling firm

St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, CA.

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.

FDA event 89816: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0964-2022	Merlin PCS 3650 programmer Model 3330 software	30,069 devices with software	Class II	Ongoing	27 Apr 2022
Z-0965-2022	Merlin 2 PCS MER3700 programmer Model MER3400 software	401 devices with software	Class II	Ongoing	27 Apr 2022

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 2022: 839
Share of these events in Class II: 88%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of St. Jude Medical, Cardiac Rhythm Management Division
Initiated	Product (first record)	Type	Class	Records
17 Jun 2022	Merlin PCS 3650 programmer Model 3330 software	Device	Class II	3
10 Mar 2022	Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q	Device	Class II	3
22 Jan 2020	Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (0541473450	Device	Class II	1
13 Apr 2018	Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile.	Device	Class II	1
3 Nov 2015	Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for lon	Device	Class I	1
18 Aug 2015	Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pace	Device	Class II	1
18 Dec 2014	Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmit	Device	Class II	1
19 Aug 2014	Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse	Device	Class II	1

St. Jude Medical, Cardiac Rhythm Management Division: all 9 events

Official channels

FDA enforcement report Z-0964-2022The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 89816. https://recallregister.com/fda/ii/89816/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

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 - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY,…
What quantity of product is in FDA event 89816?: The event has 2 product records. The first record gives this quantity: 30,069 devices with software
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2022 have the same class?: 88% of the 839 device events that started in 2022 are in Class II.