Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC P

Is my product affected?

Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automat

• UPC 00885074300252
• UPC 00885074300276

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

What happened

Medtronic is recalling approximately 8,821 units of the EnTrust SingleChamber Implantable Cardioverter Defibrillator with specific serial numbers distributed worldwide and throughout the United States. The devices may experience a loss of high voltage and anti-tachycardia pacing therapy as the battery approaches end-of-life. In certain circumstances, the device may skip the normal elective replacement indicator alert and instead immediately display an End of Life Observation status without warning, which can occur when there is insufficient remaining battery capacity to properly charge the high voltage circuits.

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

Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.

Details from the source

Reason for recall: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy. Distribution: Worldwide Distribution - US Nationwide Quantity: 8821 units Lot/code info: Product UPN/GTIN: 00885074300252 Serial Numbers: PNT600036S PNT600042S PNT600053S PNT600056S PNT600057S PNT600059S PNT600063S PNT600064S PNT600067S PNT600070S PNT600072S PNT600077S PNT600078S PNT600084S PNT600086S PNT600088S PNT600089S PNT600090S PNT600093S PNT600094S PNT600097S PNT600100S PNT600101S PNT600102S PNT600103S PNT600104S PNT600105S PNT600107S PNT600108S PNT600109S PNT600111S PNT600113S PNT600115S PNT600118S PNT600119S PNT600135S PNT600157S PNT600159S PNT600160S PNT600161S PNT600167S PNT600169S PNT600171S PNT600177S PNT600179S PNT600180S PNT600181S PNT600182S PNT600183S PNT600184S PNT600185S PNT600186S PNT600187S PNT600188S PNT600189S PNT600192S PNT600193S PNT600194S PNT600195S PNT600198S PNT600201S PNT600202S PNT600203S PNT600205S PNT600207S PNT600209S PNT600210S PNT600211S PNT600212S PNT600213S PNT600216S PNT600217S PNT600218S PNT600219S PNT600220S PNT600221S PNT600223S PNT600225S PNT600226S PNT600227S PNT600228S PNT600229S PNT600230S PNT600231S PNT600232S PNT600233S PNT600234S PNT600235S PNT600238S PNT600239S PNT600241S PNT600242S PNT600243S PNT600244S PNT600245S PNT600246S PNT600247S PNT600248S PNT600249S PNT600250S PNT600251S PNT600252S PNT600253S PNT600254S PNT600255S PNT600256S PNT600257S PNT600267S PNT600278S PNT600281S PNT600316S PNT600317S PNT600337S PNT600349S PNT600365S PNT600369S PNT600377S PNT600392S PNT600393S PNT600394S PNT600395S PNT600396S PNT600397S PNT600398S PNT600399S PNT600400S PNT600402S PNT600403S PNT600404S PNT600405S PNT600412S PNT600416S

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 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 bive2018-06-21
• 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

All FDA (Device enforcement) recalls