# P010015: Medtronic Insync (TM) Biventrical Pacing System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Aug 28, 2001 after 179 days
- Product code: LWP (Implantable Pulse Generator, Pacemaker (Non-Crt))
- Device class: 3
- Recalls of this device: 10 (0 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.
0 of 1 device in its family (counting itself) have 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
- Jun 17, 2025 · Class II · Z-2128-2025: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon inter
- Jun 17, 2025 · Class II · Z-2127-2025: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon inter
- Jun 4, 2020 · Class II · Z-2513-2020: There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurem
- Jun 4, 2020 · Class II · Z-2512-2020: There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurem
- Jun 4, 2020 · Class II · Z-2511-2020: There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurem
- Jun 21, 2018 · Class II · Z-2414-2018: 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 Paci
- Jun 21, 2018 · Class II · Z-2415-2018: 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 Paci
- Jun 21, 2018 · Class II · Z-2412-2018: 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 Paci
- Jun 21, 2018 · Class II · Z-2413-2018: 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 Paci
- Nov 9, 2015 · Class II · Z-0342-2016: Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.

Source page: https://510kreport.com/device/P010015
Methodology: https://510kreport.com/methodology