St Jude Medical Recalls Promote Quadra ICDs for Security Firmware Update
St Jude Medical is recalling Promote Quadra implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
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: The recall involves a security vulnerability in high-risk medical devices (ICDs/CRT-Ds) where unauthorized access could pose a risk of harm, but no injuries or illnesses have been reported, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
St Jude Medical Inc. is recalling 10,425 units of Promote Quadra, Sterile EO, high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D). The recall is intended to release new firmware that strengthens security by providing an additional layer of protection against unauthorized device access.
The affected devices were distributed nationwide in the U.S. For older generation devices that are not capable of accepting the new firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Customers should contact St Jude Medical Inc. to determine if their specific device is affected and to discuss the firmware update or the option to disable RF communication.
The recalled product
- Product
- Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 10,425
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by St Jude Medical Inc. 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.
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