Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF# CDHFA500Q SN #111004346, Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- St. Jude Medical, Cardiac Rhythm Management Division
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Product Codes/Lot Numbers:
REF# CDHFA500Q SN #111004346, Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0990-2022
Related Recalls
Merlin 2 PCS MER37000 programmer Model MER3400 software
St. Jude Medical, Cardiac Rhythm Management Division
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
Merlin PCS 3650 programmer Model 3330 software
St. Jude Medical, Cardiac Rhythm Management Division
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
Merlin.net model MN5000 Software
St. Jude Medical, Cardiac Rhythm Management Division
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.