FDA Device recall Z-2414-2018
Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization the…
- FDA Device
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization the… 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-2414-2018 |
| 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 CRT-P MRI SureScan, REF W1TR04 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) 00643169735699 Serial Numbers: RNU601594S RNU601595S RNU601596S RNU601115S RNU601438S RNU601430S…GTIN/UPN: (a) 00643169735699 Serial Numbers: RNU601594S RNU601595S RNU601596S RNU601115S RNU601438S RNU601430S RNU600949S RNU600950S RNU601300S RNU601302S RNU601451S RNU601453S RNU600517S RNU600582S RNU600629S RNU600664S RNU600665S RNU600666S RNU600684S RNU600735S RNU600736S RNU600737S RNU600738S RNU600739S RNU600740S RNU600741S RNU600742S RNU600743S RNU600744S RNU600746S RNU600747S RNU600997S RNU601014S RNU601503S RNU601575S RNU601577S RNU601640S RNU601641S RNU601642S RNU601643S RNU601644S RNU601645S RNU601646S RNU601647S RNU601648S RNU601649S RNU601650S RNU601651S RNU601652S RNU601653S RNU601654S RNU601655S RNU601656S RNU601657S RNU601658S RNU601659S RNU601660S RNU601661S RNU601662S RNU601663S RNU601664S RNU601665S RNU601666S RNU601667S RNU601668S RNU601669S RNU601670S RNU601671S RNU601672S RNU601673S RNU601674S RNU601675S RNU601676S RNU601678S RNU601679S RNU601680S RNU601681S RNU601682S RNU601683S RNU |
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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-2414-2018%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.