The Recall Desk
HighFDA (Devices)·Z-2441-2021·Announced 2021-09-15

Guide Catheters Recalled for Potential Sterilization Defect

Mivi Neuroscience is recalling 491 MIVI Super 90 Guide Catheters due to potential nonsterility from a pouch seal defect. The catheters are used to guide microcatheters in vascular procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a sterile medical device with a potential nonsterility hazard from a manufacturing defect. While no illnesses or injuries have been reported and the contamination is theoretical, the risk is significant given the device's use in critical vascular procedures where infection could cause serious harm.

Plain-English summary

Mivi Neuroscience Inc. is recalling 491 MIVI Super 90 Guide Catheters (referenced as MIA-9080S, MIA-9090S, and MIA-9095S in 80 cm, 90 cm, and 95 cm lengths, and their -E variants) due to a potential defect in the pouch seal that could compromise sterility.

These catheters are intended to facilitate the insertion and guidance of microcatheters into blood vessels in peripheral, coronary, and neuro-vascular systems. Use of a nonsterile device in these critical vascular procedures could increase the risk of serious infection.

The affected units were distributed in the United States (Florida, Massachusetts, New Jersey, New York, and Tennessee) and internationally (France, Hungary, Slovenia, and Spain). Specific lot numbers and expiration dates are available in the FDA recall notice.

Patients and healthcare providers should discontinue use of the recalled catheters. Clinicians should review patient records to identify individuals who may have received one of the affected devices and assess the need for appropriate follow-up care.

The recalled product

Product
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 selecte
Manufacturer
Mivi Neuroscience Inc
Category
Medical Device — Cardiovascular / Neuro-vascular
Hazard
  • nonsterility
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Cat. #MIA-9095S - Lots M20090013
  • exp. 9/10/2021
  • and M20110008
  • 10/26/2021. Cat. #MIA-9095S-E - Lots M20090012
  • 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
  • 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

Distribution

Distributed in 5 states:

  • FL
  • MA
  • NJ
  • NY
  • TN

Related recalls

Same category