The Recall Desk
HighFDA (Devices)·Z-0989-2022·Announced 2022-04-27

Gallant VR Implantable Cardioverter Defibrillator Bluetooth malfunction impairs remote monitoring

Certain Gallant VR Implantable Cardioverter Defibrillator units experience Bluetooth malfunction preventing remote monitoring and reducing battery longevity.

What this means for you

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 is a Class II recall of an implantable cardiac device affecting critical monitoring and battery function. No injuries or illnesses reported; classified as risk-of-harm product where functional defect has not yet caused reported harm.

Plain-English summary

St. Jude Medical has recalled certain Gallant VR Implantable Cardioverter Defibrillator units (REF# CDVRA500Q) due to a Bluetooth malfunction that occurs after device implantation. The recall involves serial numbers 111009251 (expiration July 31, 2022) and 810000544 (expiration October 31, 2022).

The Bluetooth malfunction causes the device to enter an inductive-only telemetry mode, resulting in loss of Bluetooth communication. Consequently, the device cannot be remotely monitored and experiences reduced battery longevity.

The recall affects two devices distributed worldwide, with US distribution in Florida and Kentucky, as well as France and Czech Republic. Patients with affected devices should contact St. Jude Medical or their healthcare provider regarding evaluation and management options.

The recalled product

Product
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Manufacturer
St. Jude Medical, Cardiac Rhythm Management Division
Category
Medical Device — Cardiac Device
Hazard
Affected units
2

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 (6)

  • REF# CDVRA500Q SN: 111009251
  • Exp Date : 31-Jul-2022
  • Material # 100173801
  • SN # 810000544
  • Exp Date: 31-Oct-2022
  • Material # 600115400 UDI# 05415067031990

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 →

Related recalls

Same manufacturer · St. Jude Medical, Cardiac Rhythm Management Division

See all →

Same hazard · bluetooth malfunction

See all →