The Recall Desk
HighFDA (Devices)·Z-1523-2021·Announced 2021-05-12

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.

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 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 card
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardiac Device
Hazard
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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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Same hazard · software error

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