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.
Reported: September 15, 2021 Initiated: July 23, 2021 #Z-2441-2021
Product Description
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.
Reason for Recall
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Details
- Recalling Firm
- Mivi Neuroscience Inc
- Units Affected
- 491 units
- Distribution
- US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.
- Location
- Eden Prairie, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mivi Neuroscience Inc. Units affected: 491 units.
Why was this product recalled? ▼
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 15, 2021. Severity: Moderate. Recall number: Z-2441-2021.
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