Z-2206-2020Class II

Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001

Name: Z-2206-2020 Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Creator: Medtronic Inc.
Published: 2020-04-10
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-04-10 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. began a recall of Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001 on 2020-04-10. FDA classified it as Class II and gives the reason as "Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2206-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-10
Posted: 2020-06-03
Terminated: 2021-04-27
Recalling firm: Medtronic, Inc.
Product: Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis (DKA), potentially followed by secondary multi-organ failure (primarily renal and hepatic) and/or death.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic initiated verbal communication with affected consignees on April 10, 2020 via phone call and provided affected consignees with an "Urgent Field Safety Notice" via email between the dates of 04/24/20 - 4/30/20. . In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Immediately identify and quarantine all unused affected pumps in your inventory. 2. Return all unused affected pumps in your inventory to Medtronic. Your Medtronic Representative can assist you in the return and replacement of this pump as necessary. 3. Forward this notice to all those who need to be aware within your organization and to any organization where the affected pumps may have been transferred. Please maintain a copy of this notice in your records.
Quantity in commerce: 24 Pumps
Distribution: No US Distribution. OUS: Netherlands, France, and Sweden
Product codes and lots: Device not distributed within the US. All Pump lots produced May 21, 2019 to present containing the following serial numbers: 31359, 31360, and 31332

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2206-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2206-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)