Medtronic Inc.: Medical Device Recall in 2020 - (Recall #: Z-2206-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 10, 2020

Date Posted: June 10, 2020

Recall Number: Z-2206-2020

Event ID: 85582

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.

Status: Terminated

Product Quantity: 24 Pumps

Code Information:

Device not distributed within the US. All Pump lots produced May 21, 2019 to present containing the following serial numbers: 31359, 31360, and 31332

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated