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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65810

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

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Event summary

Timeline bucket
July 19, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Micro Therapeutics Inc, Dba Ev3 Neurovascular

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

Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.

Z-2045-2013
Recall number
Z-2045-2013
Initiated
July 19, 2013
Classification
Class II
Status
Terminated
Quantity
62 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "

Code information

Model/Lot Numbers: FA-71400-25 / 9747602 FA-77350-18 / 9749412 FA-77400-20 / 9759088 FA-71500-35 / 9747604 FA-77375-16 / 9744487 FA-77425-16 / 9752788 FA-77300-16 / 9757068 FA-77375-20 / 9757065 FA-77425-20 / 9744123 FA-77325-14 / 9759141 FA-77400-14 / 9757233 FA-77425-20 / 9752438 FA-77325-16 / 9753034 FA-77400-14 / 9768698 FA-77450-18 / 9753033 FA-77325-16 / 9757024 FA-77400-16 / 9743468 FA-77475-20 / 9752787 FA-77325-18 / 9759560 FA-77400-18 / 9751579 FA-77500-20 / 9750678 FA-77350-16 / 9752785 FA-77400-20 / 9755707

Distribution pattern

US Distribution including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT and VA.