Medtronic Cardiac Device Software Affected by Data Processing Error
Medtronic is recalling software used in certain cardiac implant devices due to a data processing error that may fail to collect episode data. Approximately 18,715 devices are affected worldwide.
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 is an FDA Class II recall of a life-critical cardiac device. Although no illnesses or injuries have been reported, the software error presents a risk of harm by potentially failing to process critical cardiac device data. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High severity rating.
Plain-English summary
Medtronic Inc. is recalling the CareLink SmartSync Device Manager application software (version lower than v5.0.0) used with certain Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). A software error may cause the processing of collected episode data to fail, potentially affecting the clinical information available for device management.
Approximately 18,715 devices are affected. Distribution includes the United States, military and government facilities, and the following countries: Andorra, Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Liechtenstein, Luxembourg, Martinique, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Patients and healthcare providers should update the software to version v5.0.0 or higher. Contact Medtronic for update instructions and support. Healthcare providers should identify affected patients and schedule timely software updates.
The recalled product
- Product
- Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR…
- Affected units
- 18,715
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 (1)
- Application software lower than v5.0.0.
Distribution
Distributed nationwide across the United States.
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