Northeast Scientific NES Reprocessed Visions PV .035 IVUS Catheter Recall: Reprocessing
Northeast Scientific recalls specific lots of reprocessed IVUS catheters due to unsafe reprocessing cycles. This device is used for blood vessel imaging and may cause harm if reprocessed beyond the approved limit.
Lower-risk recall
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Contact the company
What happened, in plain English
Northeast Scientific is recalling certain lots of reprocessed IVUS catheters because they were not cleared for additional reprocessing cycles beyond what's approved. Using these catheters could lead to safety risks if reprocessed more than once. Read more at govinfonow.com/recall/62719-northeast-scientific-nes-reprocessed-visions-pv-035-ivus-catheter-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/62719-northeast-scientific-nes-reprocessed-visions-pv-035-ivus-catheter-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2334-2021
Cite this page
“Northeast Scientific NES Reprocessed Visions PV .035 IVUS Catheter Recall: Reprocessing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62719-northeast-scientific-nes-reprocessed-visions-pv-035-ivus-catheter-recall. Based on FDA recall #Z-2334-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2334-2021%22&limit=1).
Why it’s dangerous
The catheter was designed for only one reprocessing cycle as indicated by the 510k. Reprocessing it more than once could lead to safety issues due to potential degradation of the device.
Who’s affected
Healthcare professionals using the specific lots of catheters for blood vessel imaging are most at risk. Patients receiving these catheters during procedures may also be affected.
How to tell if you have this one
Check the lot numbers on the catheter packaging, which range from L0017886 to L0020553. The product is labeled as 'NES Reprocessed Visions PV .035 IVUS Catheter, Sterile' for use in blood vessel imaging.
- Brand
Northeast Scientific- Category
Medical device
What to do — step by step
Check Lot Numbers
Look for lot numbers between L0017886 and L0020553 on the catheter packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
FDA distribution: “US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Connecticut, Florida, Georgia, Illinois, Massachusetts, New Jersey, New York, North Carolina, Texas.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2334-2021 (April 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2334-2021 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.