Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS.… recallZ-0223-2022 · Cook Inc. · initiated Oct 8, 2021

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Cook Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On October 8, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were instructed to take the following actions: 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

Recall details

Recall number: Z-0223-2022
Status: Terminated
Initiated by the company: Oct 8, 2021
Recalling firm: Cook Inc.
Quantity: 4789 (OUS only)
Product code: N/A
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (5k characters)

All Lots UDI (01)00827002192614(17)211010(10)9226180 (01)00827002192614(17)211015(10)9234901 (01)00827002192614(17)211015(10)9235946 (01)00827002192614(17)211015(10)9235947 (01)00827002192614(17)211017(10)9242172 (01)00827002192614(17)211120(10)9326411 (01)00827002192614(17)211120(10)9326412 (01)00827002192614(17)211121(10)9328622 (01)00827002192614(17)211130(10)9347132 (01)00827002192614(17)211203(10)9351027 (01)00827002192614(17)211204(10)9354000 (01)00827002192614(17)211210(10)9370544 (01)00827002192614(17)211220(10)9396895 (01)00827002192614(17)220104(10)9419991 (01)00827002192614(17)220109(10)9431068 (01)00827002192614(17)220109(10)9431069 (01)00827002192614(17)220124(10)9472321 (01)00827002192614(17)220128(10)9480776 (01)00827002192614(17)220201(10)9492814 (01)00827002192614(17)220201(10)9492815 (01)00827002192614(17)220201(10)9492816 (01)00827002192614(17)220214(10)9524330 (01)00827002192614(17)220222(10)9545708 (01)00827002192614(17)220222(10)9545720 (01)00827002192614(17)220304(10)9568083 (01)00827002192614(17)220304(10)9568088 (01)00827002192614(17)220311(10)9583267 (01)00827002192614(17)220319(10)9604183 (01)00827002192614(17)220319(10)9604184 (01)00827002192614(17)220322(10)9611406 (01)00827002192614(17)220322(10)9613905 (01)00827002192614(17)220325(10)9617635 (01)00827002192614(17)220328(10)9626175 (01)00827002192614(17)220328(10)9626176 (01)00827002192614(17)220328(10)9626177 (01)00827002192614(17)220402(10)9638768 (01)00827002192614(17)220404(10)9643348 (01)00827002192614(17)220404(10)9643349 (01)00827002192614(17)220409(10)9654385 (01)00827002192614(17)220409(10)9654513 (01)00827002192614(17)220409(10)9654514 (01)00827002192614(17)220409(10)9655757 (01)00827002192614(17)220510(10)9730630 (01)00827002192614(17)220516(10)9743413 (01)00827002192614(17)220516(10)9743414 (01)00827002192614(17)220522(10)9760371 (01)00827002192614(17)220611(10)9802149 (01)00827002192614(17)220620(10)9826728 (01)00827002192614(17)220620(10)9826729 (01)00827002192614(17)220627(10)9840896 (01)00827002192614(17)220628(10)9844564 (01)00827002192614(17)220701(10)9850898 (01)00827002192614(17)220822(10)9966055 (01)00827002192614(17)220826(10)9971573 (01)00827002192614(17)220826(10)9971744 (01)00827002192614(17)220910(10)10002117 (01)00827002192614(17)220917(10)10016709 (01)00827002192614(17)220919(10)10025480 (01)00827002192614(17)220923(10)10031245 (01)00827002192614(17)221023(10)10102218 (01)00827002192614(17)221023(10)10102219 (01)00827002192614(17)221024(10)10105936 (01)00827002192614(17)221024(10)10105937 (01)00827002192614(17)221113(10)10148679 (01)00827002192614(17)221114(10)10151314 (01)00827002192614(17)221118(10)10157368 (01)00827002192614(17)221121(10)10166249 (01)00827002192614(17)221219(10)10224967 (01)00827002192614(17)221219(10)10224968 (01)00827002192614(17)230204(10)10307597 (01)00827002192614(17)230212(10)10324494 (01)00827002192614(17)230220(10)10342526 (01)00827002192614(17)230220(10)10342529 (01)00827002192614(17)230421(10)13145971 (01)00827002192614(17)230421(10)13145972 (01)00827002192614(17)230514(10)13193150 (01)00827002192614(17)230514(10)13193151 (01)00827002192614(17)230609(10)13235106 (01)00827002192614(17)230609(10)13235107 (01)00827002192614(17)230622(10)13260302 (01)00827002192614(17)230714(10)13304618 (01)00827002192614(17)230716(10)13311621 (01)00827002192614(17)230716(10)13311622 (01)00827002192614(17)230716(10)13311623 (01)00827002192614(17)231009(10)13481714 (01)00827002192614(17)231009(10)13481715 (01)00827002192614(17)231112(10)13553814 (01)00827002192614(17)231202(10)13602045 (01)00827002192614(17)231202(10)13602046 (01)00827002192614(17)231202(10)13602047 (01)00827002192614(17)231204(10)13606368 (01)00827002192614(17)231204(10)13606369 (01)00827002192614(17)231204(10)13606370 (01)00827002192614(17)231204(10)13606371 (01)00827002192614(17)240120(10)13702632 (01)00827002192614(17)240120(10)13702633 (01)00827002192614(17)240120(10)13702634 (01)00827002192614(17)240122(10)13707721 (01)00827002192614(17)240311(10)13817370 (01)00827002192614(17)240311(10)13817371 (01)00827002192614(17)240311(10)13817372 (01)00827002192614(17)220222(10)9545708X (01)00827002192614(17)191110(10)NS7433921 (01)00827002192614(17)191201(10)NS7482244 (01)00827002192614(17)191201(10)NS7482246 (01)00827002192614(17)191201(10)NS7482247 (01)00827002192614(17)200712(10)NS8059999 (01)00827002192614(17)211003(10)NS9209497 (01)00827002192614(17)211003(10)NS9209498 (01)00827002192614(17)211003(10)NS9209499 (01)00827002192614(17)211003(10)NS9209500 (01)00827002192614(17)211004(10)NS9212134

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Endrys G19261
Cook Incorporated · Trocar
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 88808).

Z-0222-2022 · Terminated
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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