# P910073: Endotak Lead System

- Pathway: PMA
- Applicant: Boston Scientific
- Decided: Aug 26, 1993 after 616 days
- Product code: LWS (Implantable Cardioverter Defibrillator (Non-Crt))
- Device class: 3
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 24, 2025 · Class I · Z-2325-2025: 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 ha
- Jul 24, 2025 · Class I · Z-2326-2025: 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 ha
- Jul 24, 2025 · Class I · Z-2327-2025: 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 ha

Source page: https://510kreport.com/device/P910073
Methodology: https://510kreport.com/methodology