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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93401

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

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Event summary

Timeline bucket
July 13, 2020
Product types
Device
Classifications
Class II
Statuses
Completed
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 SynchroMed, Model A10

Z-0522-2024
Recall number
Z-0522-2024
Initiated
July 13, 2020
Classification
Class II
Status
Completed
Recalling firm
Medtronic Inc.
Quantity
2543 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.

Code information

GTIN 00643169771031, All serial numbers with software version 1.1.300.

Distribution pattern

Foreign Distribution