Cook recalls Transseptal Needle with Catheter (RPN TSN-17-75.0-ENDRYS) due to potential rust on the needle that could cause inflammatory reactions or serious injury.
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 inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.
Cook is recalling Transseptal Needles with Catheters because they may have rust inside or outside the needle. This rust could cause inflammation, serious reactions, or even death during medical procedures.
Rust on the needle can cause inflammation or severe reactions during medical procedures. In extreme cases, this could lead to permanent health issues or death.
Medical professionals using this device for procedures like heart surgeries are most at risk. Patients undergoing these procedures may also be affected if the device is used.
Check for the product name 'Transseptal Needle with Catheter' with the RPN TSN-17-75.0-ENDRYS and GPN G19261. All units listed in the UDI codes above are affected.
Inspect the needle for rust on the inside or outside. If rust is present, stop using the device immediately.
Reach out to Cook Inc. for guidance on next steps if rust is found or if you have the product.
The product may contain rust that could cause inflammation or serious injury. Do not use if rust is present.
Check for the RPN TSN-17-75.0-ENDRYS and GPN G19261 codes listed in the UDI codes above.
Stop using the device immediately and contact Cook Inc. for further instructions.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0223-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-0223-2022 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
