PMA · Approved
Recalled · Class I · 2026Medtronic (R) Synchromed (TM) Pump & Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · LKK Pump, Infusion, Implanted, Programmable
Approved on Mar 14, 1988 through premarket approval, which rests on the device’s own clinical evidence after a 770-day review. It has a Class I recall. It has been recalled 40 times, including 2 Class I recalls.
- Decided
- Mar 14, 1988
- Review
- 770 days
- Class
- Class III
- Product code
- LKK
- Recalls
- 40 (2 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P860004 has 442 supplements since 1988: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
1988high 29 (2018) · low 1 (1993)2026
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1988 | 2 |
| 1989 | 6 |
| 1990 | 3 |
| 1991 | 5 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 7 |
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 6 |
| 2003 | 2 |
| 2004 | 5 |
| 2005 | 13 |
| 2006 | 9 |
| 2007 | 4 |
| 2008 | 9 |
| 2009 | 15 |
| 2010 | 20 |
| 2011 | 23 |
| 2012 | 16 |
| 2013 | 19 |
| 2014 | 15 |
| 2015 | 28 |
| 2016 | 20 |
| 2017 | 26 |
| 2018 | 29 |
| 2019 | 25 |
| 2020 | 21 |
| 2021 | 16 |
| 2022 | 21 |
| 2023 | 18 |
| 2024 | 14 |
| 2025 | 19 |
| 2026 | 7 |
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.
1 device in this family has a Class I recall. 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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2026 | Class II | Z-2201-2026 | Under Investigation by firm | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be… |
| Jan 9, 2025 | Class II | Z-1506-2025 | Under Investigation by firm | Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. |
| May 10, 2024 | Class II | Z-2352-2024 | Device Design | Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter… |
| Nov 13, 2023 | Class II | Z-0615-2024 | Under Investigation by firm | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after… |
| Nov 13, 2023 | Class II | Z-0614-2024 | Under Investigation by firm | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after… |
| Jul 13, 2020 | Class II | Z-0522-2024 | Software Design Change | The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm. |
| Oct 11, 2019 | Class I | Z-0508-2020 | Process control | There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall. |
| Sep 21, 2017 | Class III | Z-0537-2018 | Other | There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump. |
| Aug 9, 2017 | Class II | Z-0896-2018 | Device Design | Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted. |
| Oct 3, 2016 | Class I | Z-0788-2017 | Under Investigation by firm | Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump… |
| Feb 9, 2016 | Class II | Z-1271-2016 | Under Investigation by firm | Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with incorrect outer package labels. As a result, it may not… |
| Apr 10, 2015 | Class II | Z-1681-2015 | Process control | Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function. |
| Jan 14, 2011 | Not classified | Z-1061-2011 | Other | This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management recommendations that will be added to our… |
| Jan 14, 2011 | Not classified | Z-1062-2011 | Other | This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management recommendations that will be added to our… |
| Jan 14, 2011 | Not classified | Z-1060-2011 | Other | This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management recommendations that will be added to our… |
| Jul 1, 2009 | Not classified | Z-2276-2009 | Nonconforming Material/Component | This recall is related to the potential for reduced battery performance in a small percentage of Medtronic Model 8637 SynchroMed II pumps with batteries manufactured during two distinct time periods prior to April 2005. Nature of the… |
| Mar 23, 2009 | Not classified | Z-1214-2010 | Other | Routine monitoring of Medtronic's vigilance program identified user related programming errors. Medtronic has received reports of both overdose and underdose that were the result of programming use of SynchroMed implantable infusion… |
| Apr 14, 2008 | Not classified | Z-2174-2008 | Device Design | The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period. |
| Apr 14, 2008 | Not classified | Z-2171-2008 | Device Design | The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period. |
| Apr 14, 2008 | Not classified | Z-2173-2008 | Device Design | The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period. |
| Apr 14, 2008 | Not classified | Z-2172-2008 | Device Design | The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period. |
| Jan 16, 2008 | Not classified | Z-1153-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1146-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1149-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1147-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1144-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1148-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1151-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1150-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1142-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1152-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1145-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1143-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Jan 16, 2008 | Not classified | Z-1154-2008 | Device Design | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of… |
| Aug 3, 2007 | Not classified | Z-0739-2008 | Device Design | Pump motor stall due to gear shaft wear |
| Jul 21, 2006 | Not classified | Z-1415-06 | Other | Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation. |
| Jul 21, 2006 | Not classified | Z-1414-06 | Other | Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation. |
| Nov 19, 2004 | Not classified | Z-0391-05 | Other | Outer package of Lioresal Intrethecal Refill Kit, model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml). Lot N0016487 incorrectly contains 1-20 ml ampule of… |
| Aug 24, 2004 | Not classified | Z-1334-04 | Other | With the Model 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Programmer, users may have mistakenly entered a periodic bolus interval into… |
| Jul 23, 2004 | Not classified | Z-1384-04 | Other | The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component… |
The 5 latest of 40 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LKK devicesLKK Pump, Infusion, Implanted, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKK
22in 2025
2007high 57 (2019) · low 8 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LKK
Too few LKK 510(k)s in any year since 2007 to give a median.
Recalls per year · LKK
5in 2024
2007high 35 (2008) · low 0 (2013)2026
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · LKK
5,732in 2025
2007high 8,461 (2016) · low 2,676 (2007)2025
MAUDE reports naming product code LKK, 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 | 8 | — | 16 | 2,676 |
| 2008 | 8 | — | 35 | 3,398 |
| 2009 | 10 | — | 6 | 3,225 |
| 2010 | 29 | — | 2 | 4,067 |
| 2011 | 34 | — | 4 | 3,913 |
| 2012 | 33 | — | 3 (2) | 5,557 |
| 2013 | 33 | — | 0 | 8,055 |
| 2014 | 28 | — | 0 | 7,458 |
| 2015 | 40 | — | 0 | 8,451 |
| 2016 | 30 | — | 1 (1) | 8,461 |
| 2017 | 42 | — | 2 | 7,751 |
| 2018 | 55 | — | 0 | 6,936 |
| 2019 | 57 | — | 1 (1) | 5,652 |
| 2020 | 49 | — | 1 | 5,115 |
| 2021 | 32 | — | 0 | 4,713 |
| 2022 | 32 | — | 0 | 4,310 |
| 2023 | 19 | — | 2 | 4,041 |
| 2024 | 22 | — | 5 | 4,618 |
| 2025 | 22 | — | 0 | 5,732 |
| 2026 | 9 | — | 2 | — |
https://510kreport.com/device/P860004 · printed Nov 6, 2026
Cite this page
510(k) Report. “P860004: Medtronic (R) Synchromed (TM) Pump & Infusion System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P860004
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026