—#181272

Product

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

FDA product code: LKK — Pump, Infusion, Implanted, Programmable
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: Device not distributed within the US. All Pump lots produced May 21, 2019 to present containing the following serial numbers: 31359, 31360, and 31332

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc.
Address: 18000 Devonshire St, Northridge, California 91325-1219

Distribution

Distribution pattern: No US Distribution. OUS: Netherlands, France, and Sweden

Timeline

Recall initiated: 2020-04-10
Posted by FDA: 2020-06-03
Terminated: 2021-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181272. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.