Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy

Is my product affected?

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 bive

• UPC 00643169735637
• UPC 00643169891401

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling 1,842 units of Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan implantable pulse generators worldwide due to a potential device reset that could occur from a timing interaction between two device features: the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature. These devices are implanted to provide cardiac resynchronization therapy for heart patients.

The recall affects devices with specific serial numbers beginning with "RNO" (such as RNO201997H, RNO202010H, and many others listed in the recall notice). The source document does not specify what consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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).

Details from the source

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). Distribution: Worldwide Distribution - US Nationwide Quantity: 1842 units Lot/code info: 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 RNO201925H RNO201928H RNO201930H RNO201934H RNO201936H RNO201938H RNO201939H RNO201940H RNO201944H RNO201945H RNO201947H RNO201948H RNO201950H RNO201952H RNO201953H RNO201956H RNO201960H RNO201968H RNO201969H RNO201971H RNO201973H RNO200252H RNO200269H RNO201907H RNO201912H RNO201913H RNO201918H RNO201920H RNO201924H RNO201935H RNO201946H RNO201904H RNO200829H RNO200809H RNO200823H RNO200087H RNO201066H RNO201821H RNO201358H RNO200859H RNO201768H RNO201082H RNO200571H RNO200547H RNO201286H RNO200520H RNO201181H RNO201431H RNO200544H RNO201490H RNO200860H RNO201019H RNO200977H RNO

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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