FDA Device recall Z-2413-2018
Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronizatio…
- FDA Device
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronizatio… by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ve….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2413-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-21 |
| Published | 2018-07-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.
Reason
Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).
Identifiers
| code_info | GTIN/UPN: (a) 00643169735644 Serial Numbers: RNP202329H RNP206542H RNP204079H RNP204773H RNP204816H RNP206419H…GTIN/UPN: (a) 00643169735644 Serial Numbers: RNP202329H RNP206542H RNP204079H RNP204773H RNP204816H RNP206419H RNP206432H RNP206445H RNP206456H RNP206491H RNP206511H RNP206515H RNP206522H RNP206527H RNP206528H RNP206531H RNP206541H RNP206545H RNP206550H RNP206551H RNP206552H RNP206555H RNP206560H RNP206561H RNP206568H RNP206576H RNP206577H RNP206578H RNP206580H RNP206581H RNP206586H RNP206587H RNP206574H RNP206595H RNP206598H RNP206579H RNP206606H RNP206610H RNP206582H RNP206584H RNP206585H RNP206611H RNP206614H RNP206588H RNP206615H RNP206590H RNP206591H RNP206592H RNP206593H RNP206616H RNP206596H RNP206597H RNP206618H RNP206599H RNP206601H RNP206602H RNP206605H RNP206627H RNP206629H RNP206630H RNP206612H RNP206635H RNP206638H RNP206639H RNP206640H RNP206620H RNP206621H RNP206622H RNP206641H RNP206643H RNP206647H RNP206631H RNP206632H RNP206633H RNP206655H RNP206660H RNP206663H RNP206664H RNP206642H RNP |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2413-2018%22
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