Spectranetics recalls Turbo-Elite Laser Atherectomy Catheters due to mismatched product labels on exterior boxes and internal pouches. This labeling error may cause confusion in medical use.
Incorrect product labeling. Exterior product box label does not match internal pouch label.
Spectranetics is recalling several models of Turbo-Elite Laser Atherectomy Catheters because the labels on the product boxes don't match the labels inside the pouches. This mismatch could lead to confusion during medical procedures, potentially affecting patient safety.
The exterior box labels do not match the internal pouch labels, which could cause healthcare providers to use the wrong catheter model during procedures. This mismatch might lead to incorrect treatment decisions or complications.
Healthcare professionals using Spectranetics Turbo-Elite Laser Atherectomy Catheters for treating leg blockages are most at risk. Patients receiving these procedures may also be affected if the wrong catheter is used.
Check the product box for the model number and UDI code. The recalled models include 420-159, 420-006, 414-159, and 417-152 with specific lot numbers and UDI codes listed in the recall notice.
Verify the model number and UDI code on the exterior box and internal pouch to ensure they match the listed specifications.
The recall is due to incorrect product labeling where the exterior box label does not match the internal pouch label.
The affected models are Spectranetics Turbo-Elite Laser Atherectomy Catheters with model numbers 420-159, 420-006, 414-159, and 417-152.
No, the recall does not require stopping use but ensures proper labeling to prevent confusion during medical procedures.
We’ve drafted a message you can send Spectranetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0509-2024 — Spectranetics Spectranetics Hello, I own a Spectranetics that is covered by recall Z-0509-2024 from Spectranetics. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
