Ultra IABP Catheter Kit recall — FDA Z-2298-2025
Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent…
Overview of recall records associated with Insightra Medical Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent…
This page summarizes recall records in which the official source identifies Insightra Medical Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.