Device recall: Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable…

Class II FDA enforcement event 77509. Recall start date: 2 Jun 2017. Status in the FDA record: Terminated. Termination date: 24 Aug 2022.

Reason for recall, in the words of FDA

The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

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, Inc. started this device recall on 2 Jun 2017. The firm address in the FDA record is in Plano, TX. FDA put the recall in Class II. FDA event 77509 has 6 product records. The first FDA enforcement report date is 19 Jul 2017. The record gives the status Terminated, with the termination date 24 Aug 2022.

FDA enforcement report The 6 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.

US Nationwide Distribution

Recalling firm

St. Jude Medical, Inc., Plano, TX.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

6 product records in the event.

FDA event 77509: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2691-2017	Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a…	8780 units	Class II	Terminated	19 Jul 2017
Z-2692-2017	Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a…	9529 units	Class II	Terminated	19 Jul 2017
Z-2693-2017	Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current…	443 units	Class II	Terminated	19 Jul 2017
Z-2694-2017	Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current…	54 units	Class II	Terminated	19 Jul 2017
Z-2695-2017	Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current…	373 units	Class II	Terminated	19 Jul 2017
Z-2696-2017	Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current…	40 units	Class II	Terminated	19 Jul 2017

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 2017: 1,091
Share of these events in Class II: 93%
Product records in this event: 6Median of the firm: 2
Events of the firm on the register: 14

Other events of the firm

Other FDA enforcement events of St. Jude Medical, Inc.
Initiated	Product (first record)	Type	Class	Records
20 Jun 2019	ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)	Device	Class I	6
11 Oct 2018	St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. J	Device	Class II	1
16 Apr 2018	Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-2	Device	Class II	12
16 Apr 2018	St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for	Device	Class II	2
9 Mar 2018	Proclaim DRG Implantable Pulse Generator, Model Number 3664	Device	Class II	1
12 Sep 2017	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3	Device	Class II	3
28 Aug 2017	Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify As	Device	Class I	2
28 Aug 2017	Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Impla	Device	Class II	10
10 Oct 2016	Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No	Device	Class I	3
31 Mar 2016	Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage:	Device	Class II	1

St. Jude Medical, Inc.: all 14 events

Official channels

FDA enforcement report Z-2691-2017The 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 77509. https://recallregister.com/fda/ii/77509/. 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: US Nationwide Distribution
What quantity of product is in FDA event 77509?: The event has 6 product records. The first record gives this quantity: 8780 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2017 have the same class?: 93% of the 1,091 device events that started in 2017 are in Class II.