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# Cook Medical Recalls Transseptal Needle
- URL: https://www.fdaweb.com/cook-medical-recalls-transseptal-needle/
- Published: 2021-10-20T12:00:00.000Z
- Updated: 2026-09-14T17:19:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150409

FDA says Cook Medical issued a 10/8 recall of its transseptal needle and transseptal needle with catheter. The recall covers all unexpired lots for both products, an agency [statement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cook-medical-issues-voluntary-recall-transseptal-needle-and-transseptal-needle-catheter?ref=fdaweb.com#recall-announcement) says. The needles were recalled due to complaints of rust on the products. The notice says that the use of affected products could result in increased procedure time and inflammatory reactions, including systemic reactions that may lead to permanent impairment or death.

Cook Medical says it has received no reports of injury or illness related to the recall. The company says it received four complaints where the presence of rust was identified before patient contact.