PMA · Approved
Recalled · Class II · 2025Medtronic Insync (TM) Biventrical Pacing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Approved on Aug 28, 2001 through premarket approval, which rests on the device’s own clinical evidence after a 179-day review. It has been recalled 10 times.
- Decided
- Aug 28, 2001
- Review
- 179 days
- Class
- Class III
- Product code
- LWP
- Recalls
- 10
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P010015 has 574 supplements since 2001: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2001 | 2 |
| 2002 | 4 |
| 2003 | 5 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 8 |
| 2007 | 8 |
| 2008 | 18 |
| 2009 | 19 |
| 2010 | 26 |
| 2011 | 43 |
| 2012 | 32 |
| 2013 | 40 |
| 2014 | 30 |
| 2015 | 32 |
| 2016 | 28 |
| 2017 | 35 |
| 2018 | 36 |
| 2019 | 37 |
| 2020 | 37 |
| 2021 | 27 |
| 2022 | 23 |
| 2023 | 18 |
| 2024 | 25 |
| 2025 | 21 |
| 2026 | 16 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 17, 2025 | Class II | Z-2128-2025 | Software design | 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 interrogation with a SmartSync Device… |
| Jun 17, 2025 | Class II | Z-2127-2025 | Software design | 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 interrogation with a SmartSync Device… |
| Jun 4, 2020 | Class II | Z-2513-2020 | Software design | 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 measurements, Capture Management", Atrial Lead… |
| Jun 4, 2020 | Class II | Z-2512-2020 | Software design | 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 measurements, Capture Management", Atrial Lead… |
| Jun 4, 2020 | Class II | Z-2511-2020 | Software design | 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 measurements, Capture Management", Atrial Lead… |
| Jun 21, 2018 | Class II | Z-2414-2018 | Device Design | 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 Pacing feature (VSP). |
| Jun 21, 2018 | Class II | Z-2415-2018 | Device Design | 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 Pacing feature (VSP). |
| Jun 21, 2018 | Class II | Z-2412-2018 | Device Design | 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 Pacing feature (VSP). |
| Jun 21, 2018 | Class II | Z-2413-2018 | Device Design | 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 Pacing feature (VSP). |
| Nov 9, 2015 | Class II | Z-0342-2016 | Device Design | 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. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LWP devicesLWP Implantable Pulse Generator, Pacemaker (Non-Crt): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWP
46in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWP
Too few LWP 510(k)s in any year since 2007 to give a median.
Recalls per year · LWP
21in 2025
Class I (26 since 2007) Class II/III not classified
Adverse event reports per year · LWP
11,931in 2025
MAUDE reports naming product code LWP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 58 | — | 7 | 49 |
| 2008 | 87 | — | 2 | 496 |
| 2009 | 78 | — | 8 | 805 |
| 2010 | 66 | — | 7 | 678 |
| 2011 | 91 | — | 0 | 684 |
| 2012 | 123 | — | 0 | 1,087 |
| 2013 | 116 | — | 2 | 5,164 |
| 2014 | 126 | — | 2 | 9,400 |
| 2015 | 97 | — | 2 | 9,422 |
| 2016 | 97 | — | 1 | 12,354 |
| 2017 | 116 | — | 21 | 11,643 |
| 2018 | 97 | — | 0 | 14,936 |
| 2019 | 88 | — | 0 | 9,627 |
| 2020 | 90 | — | 0 | 8,989 |
| 2021 | 70 | — | 0 | 9,374 |
| 2022 | 65 | — | 0 | 14,286 |
| 2023 | 54 | — | 0 | 12,633 |
| 2024 | 58 | — | 4 (4) | 10,495 |
| 2025 | 46 | — | 21 (21) | 11,931 |
| 2026 | 40 | — | 1 (1) | — |
https://510kreport.com/device/P010015 · printed Nov 6, 2026
Cite this page
510(k) Report. “P010015: Medtronic Insync (TM) Biventrical Pacing System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P010015
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026