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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72115

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

Open FDA event record

Event summary

Timeline bucket
September 29, 2015
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 Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.

Z-0200-2016
Recall number
Z-0200-2016
Initiated
September 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Medtronic Inc.
Quantity
64 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
64 units of Achieve Electrical Cables were shipped with a potential sterility breach.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

64 units of Achieve Electrical Cables were shipped with a potential sterility breach.

Code information

Lot U531

Distribution pattern

Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.