FDA-Device2026-05-20Class IIPACKAGING DEFECT
Medtronic Marinr Steerable electrophysiology catheter recalled for incomplete sterile seals
Nationwide distributionMedical devices
What this means
Medtronic discovered that certain lots of the Marinr Steerable reprocessed electrophysiology catheter have incomplete seals on the sterile packaging. This affects 87 units distributed in the US, Canada, and Israel. No injuries have been reported.
- Check if you have one of the affected lot numbers (4147881, 4760091, 4848398, 4966192, 4995002, 5022496, 5053580, or others listed in the recall notice).
- Do not use affected catheters.
- Contact Medtronic immediately for instructions on return or replacement.
The agency's original wording
Hazard
Incomplete seals on sterile product
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide and the countries of Israel and Canada.
Affected count
87 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2199-2026More Stryker recalls
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