PMA · Approved
Recalled · 2011Medtronic Isomed 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 Jul 21, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 389-day review. It has been recalled 15 times.
- Decided
- Jul 21, 2000
- Review
- 389 days
- Class
- Class III
- Product code
- LKK
- Recalls
- 15
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P990034 has 36 supplements since 2000: 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 |
|---|---|
| 2000 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 6 |
| 2011 | 5 |
| 2012 | 2 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 1 |
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 LKK? 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 |
|---|---|---|---|---|
| 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… |
| Feb 4, 2008 | Not classified | Z-1903-2008 | Process control | Medtronic is retrieving all unused packages of ISOMED Refill Kit Model 8553, Lot 60538731. This lot of product was released using incorrect endotoxin specification limits. Endotoxin contamination can potentially lead to fever, malaise… |
| 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… |
The 5 latest of 15 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
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
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · LKK
5,732in 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/P990034 · printed Nov 6, 2026
Cite this page
510(k) Report. “P990034: Medtronic Isomed Infusion System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P990034
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026