Reported Apr 27, 2022 · Ongoing
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
St. Jude Medical, Cardiac Rhythm Management Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical, Cardiac Rhythm Management Division · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
- Lot codes and dates
- REF# CDHFA500Q SN #111004346
- Exp Date30-Jun-2022 Material # 100173746
- UDI05415067032010
- Amount recalled
- 1
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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