Boston Scientific recalls specific Guider Softip XF catheters with incorrect tip curve shape that may cause improper guidance during procedures. Affected units have unique identifiers; contact for remedy.
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
Boston Scientific is recalling certain Guider Softip XF guide catheters that were manufactured with the wrong tip curve shape. This could lead to improper guidance during medical procedures, potentially causing complications.
The catheters have an MPXF tip curve instead of the required 40XF tip curve. This incorrect shape could cause the catheter to guide improperly during medical procedures, potentially leading to complications.
Healthcare professionals using these catheters for medical procedures are most at risk. Patients receiving these catheters during procedures may also be affected.
Check for the unique identifier UDI/DI 08714729202486 or Lot/Batch numbers 27339850 (use by 2021-05-18) or 29308869 (use by 2025-04-27).
Identify the unique identifier UDI/DI 08714729202486 or Lot/Batch numbers 27339850 or 29308869 on the catheter packaging.
The correct tip curve shape is 40XF, but the recalled products have an MPXF tip curve shape.
Check for the unique identifier UDI/DI 08714729202486 or Lot/Batch numbers 27339850 (use by 2021-05-18) or 29308869 (use by 2025-04-27).
The recall record does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1582-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1582-2022 from Boston 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.
