Z-0988-2022Class II

Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

Name: Z-0988-2022 Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Creator: St. Jude Medical, Cardiac Rhythm Management Division
Published: 2022-03-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2022-03-10 / Open, Classified / root cause: design

FDA source

St. Jude Medical, Cardiac Rhythm Management Division began a recall of Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q on 2022-03-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0988-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-10
Posted: 2022-04-21
Recalling firm: Abbott Medical
Product: Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Abbott issued a Safety Notification For a subset of Gallant ICDS and CRT-D, Models CDVRA500Q, CDDRA500Q and CDHFA500Q on March 10, 2022. Notification was hand delivered in US. The notification includes the Patient Management Recommendations: -As the devices are unable to be followed using remote monitoring via Bluetooth connectivity, follow-ups should be conducted in-clinic using inductive telemetry. - Abbott has developed a process to attempt recovery of Bluetooth communication via a device firmware upgrade. If remote monitoring via Bluetooth communication is desired, please work with your local Abbott representative to schedule a firmware upgrade. Please complete and return the included Acknowledgement Form to [email protected] and maintain a record of this notice to ensure effectiveness of the communication. For any question, please contact Abbott Technical Support at 1-800-722-3774 (U.S.).
Quantity in commerce: 1
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
Product codes and lots: REF# CDDRA500Q SN# 111018237, Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0988-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0988-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0989-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0990-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)