FDA Device recall Z-2415-2018
Percepta Quad CRT-P MRI SureScan, REF W4TR04 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 W4TR04 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-2415-2018 |
| 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 W4TR04 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) 00643169735705 Serial Numbers: RNV601570S RNV601571S RNV601972S RNV603768S RNV603769S RNV603802S…GTIN/UPN: (a) 00643169735705 Serial Numbers: RNV601570S RNV601571S RNV601972S RNV603768S RNV603769S RNV603802S RNV602113S RNV603803S RNV603804S RNV603805S RNV603806S RNV603807S RNV603809S RNV603813S RNV603815S RNV603821S RNV603822S RNV603830S RNV603831S RNV603850S RNV603877S RNV603879S RNV603458S RNV603260S RNV603476S RNV603477S RNV603209S RNV603032S RNV602351S RNV603137S RNV603231S RNV603232S RNV602932S RNV602933S RNV602934S RNV602950S RNV602952S RNV602953S RNV602956S RNV602958S RNV602960S RNV602966S RNV602974S RNV602975S RNV602977S RNV603843S RNV603845S RNV601392S RNV601414S RNV601558S RNV601561S RNV601562S RNV601563S RNV601564S RNV601565S RNV601566S RNV601567S RNV601568S RNV601569S RNV601572S RNV601573S RNV601574S RNV601575S RNV601591S RNV601592S RNV601594S RNV601595S RNV601596S RNV601597S RNV601598S RNV601599S RNV601600S RNV601603S RNV601617S RNV601618S RNV601619S RNV601620S RNV601621S RNV601673S RNV |
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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-2415-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.