Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting...
FDA Device Recall #Z-0223-2022 — Class II — October 8, 2021
Recall Summary
| Recall Number | Z-0223-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 8, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cook Inc. |
| Location | Bloomington, IN |
| Product Type | Devices |
| Quantity | 4789 (OUS only) |
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
Reason for Recall
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.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution worldwide.
Lot / Code Information
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
Other Recalls from Cook Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0388-2022 | Class II | Flexor Check-Flo Introducer Ansel Modification ... | Nov 12, 2021 |
| Z-0387-2022 | Class II | Flexor Check-Flo Introducer Ansel Modificatio... | Nov 12, 2021 |
| Z-0414-2022 | Class II | Skinny Needle with Chiba Tip. RPN 090010, 09001... | Oct 13, 2021 |
| Z-0222-2022 | Class II | Transseptal Needle, Trocar. RPN TSNC-18-71.0, T... | Oct 8, 2021 |
| Z-0186-2022 | Class II | Flexor Check-Flo Introducer - Raabe Modificatio... | Sep 28, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.