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.
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
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.
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.
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.
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.
Look for lot numbers between L0017886 and L0020553 on the catheter packaging.
The catheter was not cleared for additional reprocessing cycles beyond the one indicated by the 510k, which could lead to safety risks.
Check the lot numbers on the packaging to see if it falls within the recalled range (L0017886 to L0020553).
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Northeast Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2334-2021 — Northeast Scientific Northeast Scientific Hello, I own a Northeast Scientific that is covered by recall Z-2334-2021 from Northeast Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
