Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricula

Is my product affected?

Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

• UPC 00613994425027

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

What happened

Medtronic is recalling the EnTrust and Escudo implantable cardioverter defibrillators (ICDs) due to a potential loss of high voltage and anti-tachycardia pacing therapy as the devices near the end of their battery life. Under certain circumstances, the device may jump directly to an End of Life Observation status without first triggering an earlier alert called an elective replacement indicator. When this occurs, there may not be enough remaining battery capacity to charge the high voltage circuits, which can result in excessively long charge times and a complete loss of critical pacing therapies.

The recall affects approximately 5,057 units distributed worldwide, including throughout the United States. The affected devices have specific serial numbers beginning with "PNT608" followed by various number combinations. The source document does not specify what action 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: 5057 units Lot/code info: Product UPN/GTIN: 00613994425027 Serial Numbers: PNT608737S PNT608738S PNT608739S PNT608740S PNT608742S PNT608743S PNT608744S PNT608745S PNT608746S PNT608748S PNT608749S PNT608750S PNT608751S PNT608752S PNT608753S PNT608754S PNT608755S PNT608756S PNT608757S PNT608758S PNT608759S PNT608760S PNT608761S PNT608762S PNT608763S PNT608764S PNT608765S PNT608766S PNT608767S PNT608768S PNT608769S PNT608770S PNT608771S PNT608772S PNT608773S PNT608774S PNT608775S PNT608776S PNT608777S PNT608778S PNT608779S PNT608780S PNT608781S PNT608782S PNT608783S PNT608784S PNT608785S PNT608786S PNT608787S PNT608788S PNT608789S PNT608790S PNT608791S PNT608792S PNT608793S PNT608794S PNT608795S PNT608796S PNT608798S PNT608799S PNT608800S PNT608801S PNT608802S PNT608803S PNT608804S PNT608805S PNT608806S PNT608807S PNT608808S PNT608809S PNT608810S PNT608830S PNT608924S PNT608926S PNT608927S PNT608930S PNT608931S PNT608932S PNT608934S PNT608938S PNT608939S PNT608940S PNT608944S PNT608945S PNT608946S PNT608947S PNT608948S PNT608949S PNT608951S PNT608952S PNT608953S PNT608954S PNT608955S PNT608956S PNT608957S PNT608958S PNT608959S PNT608960S PNT608961S PNT608962S PNT608963S PNT608964S PNT608965S PNT608966S PNT608967S PNT608968S PNT608969S PNT608970S PNT608971S PNT608972S PNT608973S PNT608974S PNT608975S PNT608976S PNT608977S PNT608978S PNT608979S PNT608980S PNT608981S PNT608982S PNT608983S PNT608984S PNT608985S PNT608986S PNT608987S PNT608988S PNT608989S PNT608990S PNT608991S PNT608992S PNT608993S PNT608994S

Source

Official record: FDA (Device enforcement) ↗

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

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