Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy

Is my product affected?

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 bive

• UPC 00643169735699
• UPC 00643169891524

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

What happened

Medtronic is recalling 1,604 units of the Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan implantable pulse generators worldwide, including in the United States. These devices are designed to provide cardiac resynchronization therapy. The recall was issued due to a potential device reset that can occur from a timing interaction between two features: the EffectivCRT Diagnostic and the Ventricular Safety Pacing (VSP) feature.

The affected devices are identified by serial numbers beginning with "RNU6" (a complete list of specific serial numbers is provided in the recall documentation). Consumers who have received one of these implanted devices and believe they have the affected model should consult their physician. The recall documentation does not specify what remedy or corrective action patients should take.

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: 1604 units Lot/code info: 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 RNU601684S RNU601685S RNU601686S RNU601687S RNU601688S RNU601689S RNU601691S RNU601692S RNU601693S RNU601694S RNU601695S RNU601696S RNU601697S RNU601698S RNU601699S RNU601700S RNU601701S RNU601702S RNU601703S RNU601704S RNU601705S RNU601708S RNU601709S RNU601711S RNU601712S RNU601713S RNU601714S RNU601716S RNU601717S RNU601719S RNU601720S RNU601723S RNU601724S RNU601726S RNU601727S RNU601729S RNU601731S RNU601732S RNU601733S RNU601734S RNU601735S RNU601736S RNU601738S RNU601739S RNU601740S RNU601741S RNU601743S RNU601753S RNU601754S RNU601755S RNU601756S RNU601757S RNU601758S RNU

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. 2018-06-21
• 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 bive2018-06-21
• 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, sequential2018-06-21
• Percepta Quad CRT-P MRI SureScan, REF W4TR04 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, sequential2018-06-21
• Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias.2018-06-21

All FDA (Device enforcement) recalls