Spectranetics recalls AngioSculpt PTCA Scoring Balloon Catheter (2.5mm outer diameter) due to incorrect carton box used. Affected units may have packaging issues but no safety hazard is reported.
The incorrect outer carton box was used for the product.
Spectranetics is recalling a specific type of balloon catheter for PTCA procedures because the product was shipped with the wrong outer carton box. This issue does not pose a safety risk to users but requires verification of the packaging.
The product was shipped with the incorrect outer carton box, which does not affect the device's function or safety. This packaging error does not create a hazard during medical use.
Healthcare professionals using the AngioSculpt PTCA Scoring Balloon Catheter for cardiac procedures may be affected. Patients receiving this device are not at risk as the issue is with packaging, not the device itself.
Check for the product name 'AngioSculpt PTCA Scoring Balloon Catheter', outer diameter 2.5mm, length 15mm, and lot number G18090030 on the label. The carton box may show incorrect labeling.
Check the carton box for correct labeling and ensure it matches the product specifications listed on the label.
No, the recall is due to incorrect packaging, not a safety hazard in the device itself.
No, the device is safe to use; the issue is with the packaging, not the device's function.
Look for the product name 'AngioSculpt PTCA Scoring Balloon Catheter', outer diameter 2.5mm, length 15mm, and lot number G18090030 on the label.
We’ve drafted a message you can send Spectranetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0576-2020 — Spectranetics Spectranetics Hello, I own a Spectranetics that is covered by recall Z-0576-2020 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.
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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.
