Abbott NT2000iX Radiofrequency (RF) generator, REF… recallZ-0209-2024 · Abbott · initiated Sep 28, 2023
Open, Classified
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 Abbott 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
Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.
FDA root cause category: Process change control
What the company is doing
Abbott issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 09/28/2023 via FedEx 2nd day delivery. The notice explained the problem, risk, and requested return of the device for inspection. Those devices which pass, will be returned. Should your device(s) fail the inspection, your local Abbott Representative can advise the consignee of alternate commercially available products.
Recall details
- Recall number
- Z-0209-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 28, 2023
- Posted by the FDA
- Nov 2, 2023
- Recalling firm
- Abbott
- Quantity
- 34 devices
- Product code
- GXD
- FDA submissions
- K111576
- Distribution
- US, Taiwan, and Colombia
Product description
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Code information (models, lots, serial numbers)
UDI/DI 05415067022417, serial numbers: 16930509, 16983330, 17583407, 17634837, 17783928, 17783930, 17905961, 17928413, 17954521, 17991999, 18047384, 18493711, 18522937, 18675068, 18690920, 18709734, 18742997, 2475-12, 2504-12, 2547-13, 2885-14, 3003-14, 3278-15, 3450-15, 3550-15, 17942357, 18003310, 18102335, 18132017, 18132092, 18657521, 18666647, 19182119, 19197174
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NT2000iX™ RFG-NT-2000St. Jude Medical, Inc. · GENERATOR, LESION, RADIOFREQUENCY2 recalls310 reports
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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