Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer...

Cook Inc. began a recall of Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip... on 2021-10-08. FDA classified it as Class II and gives the reason as "Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.