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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88408

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 23, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mivi Neuroscience 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

2 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 2

MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

Z-2441-2021
Recall number
Z-2441-2021
Initiated
July 23, 2021
Classification
Class II
Status
Terminated
Recalling firm
Mivi Neuroscience Inc
Quantity
491 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for nonsterility of product due to a possible defect in the pouch seal.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for nonsterility of product due to a possible defect in the pouch seal.

Code information

Cat. #MIA-9095S - Lots M20090013, exp. 9/10/2021; and M20110008, 10/26/2021. Cat. #MIA-9095S-E - Lots M20090012, exp. 9/10/2021; M20110007, exp. 10/26/2021; M21030017, exp. 10/26/2023; M21030018, exp. 9/10/2023; M21040003, exp. 4/24/2024; M21050014, exp. 1/27/2023; M21050015, exp. 1/27/2023; M21060002, exp. 2/7/2023; and M21060003, exp. 3/12/2023. Cat. #MIA-9090S - Lot M20110006, exp. 10/27/2021. Cat. #MIA-9090S-E - Lots M20080005, exp.8/6/2021; M20090011, exp. 9/10/2021; M20110005, exp. 10/27/2021; M21010008, exp. 12/10/2021; M21030014, exp.12/10/2023; M21030015, exp. 12/10/2023; M21050013, exp. 12/10/2023; M21060006, exp. 4/3/2022; M21060007, exp. 10/30/2022; M21060008, exp. 10/30/2022; M21060009, exp. 1/27/2023; M21060010, exp. 1/27/2023; M21060011, exp. 3/12/2023; and M21060012, exp. 12/10/2023. Cat. #MIA9080S - Lot M20110009, exp. 10/27/2021. Cat. #MIA 9080S-E - Lots M21010011, exp. 12/10/2021; M21030005, exp. 10/27/2023; M21030013, exp. 4/30/2023; M21060014, exp. 10/10/2022; M21060015, exp. 10/22/2022; M21060016, exp. 4/30/2023; and M21060017, exp. 12/10/2023.

Distribution pattern

US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.

device · product 2 of 2

MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

Z-2442-2021
Recall number
Z-2442-2021
Initiated
July 23, 2021
Classification
Class II
Status
Terminated
Recalling firm
Mivi Neuroscience Inc
Quantity
68 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for nonsterility of product due to a possible defect in the pouch seal.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for nonsterility of product due to a possible defect in the pouch seal.

Code information

Cat #MIA-9095S-IDE - Lots M20120006, exp. 9/10/2021; and M21030007, exp. 9/10/2021. Cat. #MIA-9090S-IDE - Lot M21030006, exp. 12/10/2021, and M21010009, exp. 12/10/2021.

Distribution pattern

US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.