The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0988-2022·Announced 2022-04-27

Gallant DR Implantable Cardioverter Defibrillator Bluetooth Malfunction Affects Remote Monitoring

St. Jude Medical's Gallant DR implantable cardioverter defibrillator has a Bluetooth malfunction preventing remote monitoring and reducing battery life. The device enters inductive-only telemetry mode, requiring in-clinic monitoring instead.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall affects a critical life-saving device with a functional defect that impairs remote monitoring capability. Loss of remote monitoring for an implantable cardioverter defibrillator constitutes a risk-of-harm situation, even though no illnesses or injuries have been reported.

Plain-English summary

St. Jude Medical, Cardiac Rhythm Management Division, is recalling the Gallant DR Implantable Cardioverter Defibrillator (REF# CDDRA500Q) due to a Bluetooth malfunction. The defect causes the device to enter an inductive-only telemetry mode, resulting in loss of Bluetooth communication capability.

The primary impact is the inability to remotely monitor these devices. Instead of remote communication, patients must visit their healthcare provider's clinic or office for device monitoring and checks.

Additionally, the Bluetooth malfunction results in reduced battery longevity in affected devices. No illnesses or injuries have been reported in connection with this defect.

Patients with an affected device should contact their healthcare provider to discuss monitoring options and any appropriate follow-up care.

The recalled product

Product
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Manufacturer
St. Jude Medical, Cardiac Rhythm Management Division
Category
Medical Device — Implantable Cardiovascular Device
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • REF# CDDRA500Q SN# 111018237
  • Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by St. Jude Medical, Cardiac Rhythm Management Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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