FDA Device recall Z-2412-2018
Percepta CRT-P MRI SureScan, REF W1TR01 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 W1TR01 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-2412-2018 |
| 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 W1TR01 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) 00643169735637 Serial Numbers: RNO201997H RNO202010H RNO202012H RNO202015H RNO202016H RNO202018…GTIN/UPN: (a) 00643169735637 Serial Numbers: RNO201997H RNO202010H RNO202012H RNO202015H RNO202016H RNO202018H RNO202045H RNO202049H RNO202050H RNO202051H RNO202055H RNO202056H RNO202058H RNO202062H RNO202065H RNO202067H RNO202068H RNO202069H RNO202072H RNO202075H RNO202078H RNO202083H RNO202086H RNO202087H RNO202088H RNO202092H RNO202093H RNO202094H RNO202098H RNO202099H RNO202100H RNO202101H RNO201399H RNO201985H RNO201986H RNO201989H RNO201990H RNO201994H RNO201988H RNO201995H RNO202048H RNO202090H RNO202091H RNO202011H RNO201962H RNO201966H RNO201967H RNO201970H RNO201974H RNO201977H RNO201978H RNO201980H RNO201982H RNO202013H RNO202014H RNO202017H RNO202019H RNO202037H RNO202040H RNO202042H RNO202073H RNO202079H RNO202009H RNO201922H RNO201981H RNO202034H RNO200663H RNO201582H RNO201603H RNO200042H RNO200092H RNO200202H RNO200455H RNO200550H RNO200583H RNO201033H RNO201133H RNO201837H RNO201923H RN |
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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-2412-2018%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.