The Recall Desk
HighFDA (Devices)·Z-2442-2021·Announced 2021-09-15

MIVI Super 90 8F Guide Catheter Recalled Due to Potential Sterility Defect

Mivi Neuroscience is recalling MIVI Super 90 8F Guide Catheters (investigational sterile devices) due to a potential pouch seal defect that could compromise product sterility.

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. The potential for loss of sterility on a device used in vascular procedures represents a risk of infection. No illnesses or injuries have been reported, meeting the criterion for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Mivi Neuroscience Inc is recalling MIVI Super 90 8F Guide Catheters in two sizes: a 95 cm model (REF MIA-9095S-IDE) and a 90 cm model (REF MIA-9090S-IDE). These are investigational sterile devices used to facilitate insertion and guidance of microcatheters into blood vessels in peripheral, coronary, and neurovascular systems.

The recall was initiated because of a potential defect in the pouch seal that could allow the product to lose sterility. Affected lot numbers include M20120006, M21030007 (95 cm model, expiring 9/10/2021), and M21030006, M21010009 (90 cm model, expiring 12/10/2021).

A total of 68 units were distributed in the United States to Florida, Massachusetts, New Jersey, New York, and Tennessee. Additional units were distributed internationally to France, Hungary, Slovenia, and Spain.

The recalled product

Product
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 blo
Manufacturer
Mivi Neuroscience Inc
Category
Medical Device — Vascular Guide Catheter
Hazard
  • nonsterility
  • pouch-seal-defect
  • 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 (7)

  • 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

Distributed in 5 states:

  • FL
  • MA
  • NJ
  • NY
  • TN

Related recalls

Same category