Use cautionMedical device recall · FDA · Published October 8, 2021
Cook Transseptal Needle with Catheter Recall: Rust Risk
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.
Take action
Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook Transseptal Needle with Catheter Recall: Rust Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61702-cook-transseptal-needle-with-catheter-recall-rust-risk. Based on FDA recall #Z-0223-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0223-2022%22&limit=1).
The FDA announced on Oct. 8, 2021, that Cook Inc. is recalling Transseptal Needles with Catheters due to potential rust hazards. The agency said the needles may contain rust that users might not detect. Owners should contact Cook for details on the remedy.
How to tell if you have it
Brand: Cook
Product: Transseptal Needle with Catheter
RPN: TSN-17-75.0-ENDRYS
GPN: G19261
UPC: 00827002192614
Units affected: 4,789
The hazard
According to the FDA, 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 range from increased procedural time to inflammatory reactions, including systemic reactions potentially leading to permanent impairment or death.
Context
GovInfoNow's records show Cook Inc. has 38 other recalls on record since July 31, 2017. Other recent recalls of similar products include Cook Flexor Check-Flo Introducer Ansel Modification Recall (Nov. 12, 2021), Cook Skinny Needle with Chiba Tip Recall (Oct. 13, 2021), and Cook Flexor Check-Flo Introducer Recall (Sept. 28, 2021). Other recent recalls of similar products include Cook Aurous Sizing Catheters Recall (April 2, 2026) and Cook Centimeter Sizing Catheters Recall (April 2, 2026).
How to tell if you have this one
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.
Brand
Cook
Product
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Inspect the needle for rust on the inside or outside. If rust is present, stop using the device immediately.
Contact Cook
Reach out to Cook Inc. for guidance on next steps if rust is found or if you have the product.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide. Foreign distribution worldwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0223-2022 (October 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0223-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.