CLASS II ONGOING Device recall · Reported 27 Apr 2022 · FDA Enforcement Report

Gallant HF Implantable Cardioverter Defibrillator recalled

St. Jude Medical, Cardiac Rhythm Management Division is recalling Gallant HF Implantable Cardioverter Defibrillator, distributed nationwide in the US. The recall was initiated on 10 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF# CDHFA500Q SN #111004346, Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010

Quantity recalled1

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0990-2022
FDA event ID: 89825
Recalling firm: St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, CA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Mar 2022
FDA classified: 21 Apr 2022
Reported: 27 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

10 Mar 2022	Recall initiated by company
21 Apr 2022	Classified by FDA	+42 days
27 Apr 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.

Nationwide Florida Kentucky

Questions about this recall

Why was it recalled?

Which lots are affected?

REF# CDHFA500Q SN #111004346, Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 89825

Reported	Class	Recall	Company	Reason	Where
27 Apr 2022	CLASS II	Gallant DR Implantable Cardioverter Defibrillator recalled	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	Nationwide
27 Apr 2022	CLASS II	Gallant VR Implantable Cardioverter Defibrillator recalled	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	Nationwide

More recalls from St. Jude Medical, Cardiac Rhythm Management Division

All 10

Reported	Class	Recall	Company	Reason	Where
10 Aug 2022Device	CLASS II	Merlin.net recalled by St. Jude Medical, Cardiac	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	44 states
10 Aug 2022Device	CLASS II	Merlin PCS 3650 programmer recalled by St. Jude Medical, Cardiac	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	44 states
10 Aug 2022Device	CLASS II	Merlin MER37000 programmer recalled by St. Jude Medical, Cardiac	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	44 states
27 Apr 2022Device	CLASS II	Gallant VR Implantable Cardioverter Defibrillator recalled	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	Nationwide
27 Apr 2022Device	CLASS II	Merlin MER3700 programmer recalled by St. Jude Medical, Cardiac	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	Nationwide

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All 494

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