Lower riskMedical device recall · FDA · Published August 28, 2025
Boston Scientific Extractor Pro RX Catheter Label Error Recall
Boston Scientific recalls two models of Extractor Pro RX Retrieval Balloon Catheter due to incorrect labeling of the skive hole position. This could lead to improper use during medical procedures.
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Take action
Contact the company
📍Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234
✎ GovInfoNow plain-language explainer
Boston Scientific is recalling two specific models of Extractor Pro RX Retrieval Balloon Catheter because the label incorrectly shows where the skive hole is positioned relative to the balloon. This error could cause improper use during medical procedures if the catheter is used without correcting the label. Read more at govinfonow.com/recall/51537-boston-scientific-extractor-pro-rx-catheter-label-error-recall.
“Boston Scientific Extractor Pro RX Catheter Label Error Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51537-boston-scientific-extractor-pro-rx-catheter-label-error-recall. Based on FDA recall #Z-2618-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2618-2025%22&limit=1).
The FDA announced on August 28, 2025, that Boston Scientific Corporation is voluntarily recalling Extractor Pro RX Retrieval Balloon Catheters due to incorrect labeling. The hazard involves the skive hole position being mislabeled relative to the balloon.
How to tell if you have it
Brand: Boston Scientific
Product: Extractor Pro RX Retrieval Balloon Catheter
UPN (REF): M00547030 (9-12mm Below)
UPN (REF): M00547000 (9-12mm Above)
Lot Numbers: 36398057, 36426495
Units affected: 156
The hazard
The product is incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Context
GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls of similar products include Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall (November 6, 2025), Medline Urethral Catheter Tray Recall (May 4, 2026), and Medline Medical Procedure Kits Recall (May 4, 2026).
How to tell if you have this one
Check for the model numbers M00547030 (9-12mm Below) or M00547000 (9-12mm Above) on the catheter packaging or label. These models were sold with specific lot numbers.
Brand
Boston Scientific
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Label Position
Verify the skive hole position on the catheter label to ensure it matches the intended placement (above or below the balloon).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 19 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Georgia, Idaho, Illinois, Indiana, Maine, Massachusetts, Michigan, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2618-2025 (August 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2618-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.