Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization th

Is my product affected?

Percepta Quad CRT-P MRI SureScan, REF W4TR01 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

• UPC 00643169735644

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

What happened

Medtronic Inc. is recalling approximately 6,712 units of Percepta Quad CRT-P MRI SureScan and Percepta CRT-P MRI SureScan implantable pulse generators worldwide, including throughout the United States. These devices are designed to provide cardiac resynchronization therapy for heart failure patients. The recall was initiated because of a potential timing interaction between the EffectivCRT Diagnostic and Ventricular Safety Pacing (VSP) features that could cause the device to reset.

The recall affects devices with specific serial numbers beginning with "RNP" (such as RNP202329H, RNP206542H, and many others listed in the recall documentation). The source document does not specify what actions affected consumers should take 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: 6712 units Lot/code info: GTIN/UPN: (a) 00643169735644 Serial Numbers: RNP202329H RNP206542H RNP204079H RNP204773H RNP204816H RNP206419H RNP206432H RNP206445H RNP206456H RNP206491H RNP206511H RNP206515H RNP206522H RNP206527H RNP206528H RNP206531H RNP206541H RNP206545H RNP206550H RNP206551H RNP206552H RNP206555H RNP206560H RNP206561H RNP206568H RNP206576H RNP206577H RNP206578H RNP206580H RNP206581H RNP206586H RNP206587H RNP206574H RNP206595H RNP206598H RNP206579H RNP206606H RNP206610H RNP206582H RNP206584H RNP206585H RNP206611H RNP206614H RNP206588H RNP206615H RNP206590H RNP206591H RNP206592H RNP206593H RNP206616H RNP206596H RNP206597H RNP206618H RNP206599H RNP206601H RNP206602H RNP206605H RNP206627H RNP206629H RNP206630H RNP206612H RNP206635H RNP206638H RNP206639H RNP206640H RNP206620H RNP206621H RNP206622H RNP206641H RNP206643H RNP206647H RNP206631H RNP206632H RNP206633H RNP206655H RNP206660H RNP206663H RNP206664H RNP206642H RNP206674H RNP206675H RNP206651H RNP206682H RNP206690H RNP206661H RNP206693H RNP206707H RNP206710H RNP206711H RNP206678H RNP206712H RNP206716H RNP206688H RNP206719H RNP206725H RNP206734H RNP206769H RNP206773H RNP206775H RNP206776H RNP206176H RNP206338H RNP206415H RNP206416H RNP206417H RNP206418H RNP206420H RNP206421H RNP206423H RNP206424H RNP206430H RNP206431H RNP206433H RNP206435H RNP206441H RNP206442H RNP206443H RNP206444H RNP206447H RNP206448H RNP206450H RNP206452H RNP206453H RNP206455H RNP206459H RNP206460H RNP206461H RNP206462H RNP206463H RNP206464H RNP206465H RNP206467H RNP

Source

Official record: FDA (Device enforcement) ↗

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

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