Percepta CRT-P MRI SureScan — Class II medical device recall Z-2414-2018
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2018-07-18, distributed nationwide. Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due
| Recall number | Z-2414-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2018-06-21 |
| Classified | 2018-07-10 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 1,604 units |
| UPC / GTIN / UDI-DI | 00643169735699, 00643169891524 |
| Serial numbers | RNU600141S, RNU600143S, RNU600145S, RNU600146S, RNU600147S, RNU600148S, RNU600149S, RNU600150S, RNU600151S, RNU600152S, RNU600153S, RNU600154S, RNU600156S, RNU600157S, RNU600158S, RNU600159S, RNU600160S, RNU600161S, RNU600163S, RNU600164S, RNU600165S, RNU600166S, RNU600167S, RNU600168S, RNU600169S and 475 more |
| Model numbers | W1TR04 |
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 for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2414-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.