Transseptal Needles Recalled Due to Rust Contamination Risk
Cook Inc. is recalling transseptal needles that may contain undetected rust, which could cause inflammatory reactions, systemic responses, and potentially permanent impairment.
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 for a risk-of-harm medical device where no injuries have been reported. While the potential hazards—inflammatory reactions, systemic responses, and possible permanent impairment or death—are serious, the absence of any reported illnesses and the Class II designation place this at the High severity level per the rubric.
Plain-English summary
Cook Inc. is recalling transseptal needles (model TSNC-18-71.0 and TSNC-19-56.0, general part numbers G02364 and G02365) used in medical procedures. The product consists of a transseptal needle and obturator. The recall affects approximately 31,502 units distributed in the United States and 30,166 units distributed internationally.
The needles may contain rust on the interior and/or exterior of the needle, which may not be detected by users prior to use. This rust contamination creates a risk of adverse events during medical procedures.
Potential adverse events range from increased procedural time to inflammatory reactions. At their most severe, these reactions may include systemic responses that could potentially lead to permanent impairment or death. This is classified as a Class II FDA recall.
Healthcare facilities and medical professionals should contact Cook Inc. for information about this recall and guidance regarding affected needles in their possession.
The recalled product
- Product
- Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
- Manufacturer
- Cook Inc.
- Hazard
- rust
- inflammatory-reaction
- systemic-reaction
Distribution
Distributed nationwide across the United States.
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