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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85582

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 10, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2206-2020
Recall number
Z-2206-2020
Initiated
April 10, 2020
Classification
Class II
Status
Terminated
Recalling firm
Medtronic Inc.
Quantity
24 Pumps

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

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