Transseptal Needle with Catheter Recalled Due to Rust Contamination Risk
Cook Inc. is recalling transseptal needles that may contain rust on internal or external surfaces. If used, the rust could cause increased procedural time or inflammatory reactions, potentially leading to systemic complications.
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 medical device recall for a manufacturing defect (rust contamination) with serious potential consequences including systemic reactions and permanent impairment or death. However, no cases of illness or injury are reported in the source material, and the hazards are characterized as potential adverse events rather than documented harm.
Plain-English summary
Cook Inc. is recalling all lots of the Transseptal Needle with Catheter (RPN TSN-17-75.0-ENDRYS, GPN G19261). This is a coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle used in cardiac procedures.
The devices may contain rust on the interior and/or exterior of the needle that may not be detected during use. This contamination could increase procedural time or trigger inflammatory reactions during the procedure.
At their most severe, these reactions can become systemic and potentially lead to permanent impairment or death. The devices have been distributed domestically in the United States and internationally. Healthcare providers and patients should contact Cook Inc. for instructions regarding device management.
The recalled product
- Product
- 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 inner needle
- Manufacturer
- Cook Inc.
- Hazard
- rust-contamination
- inflammatory-reaction
- systemic-reaction
Distribution
Distributed nationwide across the United States.
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