Medtronic Recalls CRT-P Quad Models Due to Software Longevity Error
Medtronic is recalling 45,411 CRT-P Quad implantable devices worldwide because a software issue overestimates battery longevity for six months before replacement is due.
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: The recall involves a risk-of-harm product (implantable cardiac device) where a software error could lead to unexpected device failure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Inc. is recalling 45,411 CRT-P Quad Models (CRT-Ps) worldwide. The affected devices include the Percepta, Serena, and Solara CRT-P MRI models, which are implantable medical devices used to treat arrhythmias related to bradycardia and cardiac resynchronization therapy (CRT).
The recall is due to a SmartSync software issue that results in an overestimation of the displayed device longevity. This error occurs during an approximate six-month window before the device triggers its Recommended Replacement Time (RRT). The issue affects all serial numbers of the listed models.
Patients with these implanted devices should contact their healthcare provider to discuss the recall and determine if a replacement is necessary to ensure the device is changed before the actual battery depletion occurs.
The recalled product
- Product
- CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and…
- Affected units
- 45,411
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)
- all serial numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 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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