Boston Scientific Guider Softip XF Catheters: Incorrect Tip Curve Shape Risk
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/60201-boston-scientific-guider-softip-xf-catheters-incorrect-tip-curve-shape.
Source Summary by GovInfoNow · govinfonow.com/recall/60201-boston-scientific-guider-softip-xf-catheters-incorrect-tip-curve-shape · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1582-2022
Cite this page
“Boston Scientific Guider Softip XF Catheters: Incorrect Tip Curve Shape Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60201-boston-scientific-guider-softip-xf-catheters-incorrect-tip-curve-shape. Based on FDA recall #Z-1582-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1582-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Healthcare professionals using these catheters for medical procedures are most at risk. Patients receiving these catheters during procedures may also be affected.
How to tell if you have this one
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).
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Check Product Details
Identify the unique identifier UDI/DI 08714729202486 or Lot/Batch numbers 27339850 or 29308869 on the catheter packaging.
How this recall unfolded
Recall timeline
FDA published this recall 22 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1582-2022 (August 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1582-2022 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.