RELIANCE 4-FRONT™/model 0636; RELIANCE 4-FRONT/ model 0662; RELIANCE 4-FRONT/ model 0663 00802526592805 P910073; RELIANC

• 3 recalls, same reason

  • Ongoing Z-2325-2025 FDA Class I ·initiated 24 Jul 2025
  • Ongoing Z-2327-2025 FDA Class I ·initiated 24 Jul 2025 ·on shared PMA P910073
  • Ongoing Z-2326-2025 FDA Class I ·initiated 24 Jul 2025 ·on shared PMA P910073

  Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade name

Endotak Lead System

Generic name

Implantable cardioverter defibrillator (non-CRT)

PMA number

P910073 ↗

FDA product code

LWS

Models / Variants

RELIANCE 4-FRONT™/model 0636

RELIANCE 4-FRONT/ model 0662

RELIANCE 4-FRONT/ model 0663 00802526592805 P910073

RELIANC

Device class

Class III

Advisory committee

Cardiovascular

FDA decision

APPR Approved

• OPAL HDx™ M004OPAL14010

  Class II

  GUDID on market

• Acuity™

  Class III

  CE/MDD

• WALLSTENT-Uni™

  Class IIb

  CE/MDD

• Multi-Point Thermal Sensor

  Class IIa

  CE/MDR

• Epic™

  Class IIb

  CE/MDD

• WallFlex™

  Class IIb

  CE/MDD

See all devices from Boston Scientific →

• What is the primary purpose of the Reliance 4-Front lead systems (models 0636, 0662, 0663) in clinical practice?

  The Reliance 4-Front lead systems are designed to detect and treat ventricular tachyarrhythmias, including ventricular tachycardia (VT) and ventricular fibrillation (VF), in patients at high risk of sudden cardiac death. This includes individuals with a history of cardiac arrest due to these arrhythmias or those with recurrent ventricular tachyarrhythmias that are not controlled by conventional medications. The leads are specifically paired with implantable cardioverter defibrillators (ICDs) to deliver life-saving shocks when abnormal heart rhythms are detected.

• Are the Reliance 4-Front leads intended for use in patients who require thoracotomy, and how are they implanted?

  No, the Reliance 4-Front leads are transvenous systems, meaning they are implanted through the venous system and do not require thoracotomy. They are inserted via a vein, typically the subclavian or jugular vein, and positioned in the heart to deliver defibrillation therapy. This approach avoids open-chest surgery, reducing recovery time and patient risk.

• How are the Reliance 4-Front leads supplied, and what components are included in the package?

  The Reliance 4-Front leads are supplied sterile and intended for single-use implantation. Each system includes the lead itself, compatible stylets for insertion, patch leads (for subcutaneous/submuscular use), and connectors designed to work with commercially available ICD pulse generators. The patch leads are specifically intended for chronic subcutaneous or submuscular implantation, not epicardial or pericardial placement.

• What regulatory pathway does the Reliance 4-Front lead system follow, and what does this mean for clinicians?

  The Reliance 4-Front lead systems are regulated under the FDA’s Premarket Approval (PMA) pathway, which is reserved for high-risk medical devices like Class III devices. This means the device has undergone rigorous clinical evaluation to ensure safety and effectiveness before approval. Clinicians can rely on this pathway as evidence of the device’s thorough review by the FDA, though they should always refer to the latest labeling for specific use cases and contraindications.

• Can the Reliance 4-Front leads be used with other pacing systems, and are there any compatibility considerations?

  Yes, the Reliance 4-Front leads can be used with bipolar pacemakers, provided there is no interaction between the pacemaker and the ICD pulse generator that could lead to nondetection or false detection of arrhythmias. Clinicians should ensure compatibility between the pacemaker, ICD, and lead system to avoid interference that could compromise therapy delivery or patient safety.