Boston Scientific Extractor Pro RX-S Catheter Label Error: Injection Location Misstated
Boston Scientific recalls 12-15mm Below Extractor Pro RX-S catheters with incorrect injection location labeling that could lead to improper use. Affected units have UPN M00547340 and lot 19343:19343209 expiring 6/3/2018.
Lower-risk recall
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
Contact the company
What happened, in plain English
Boston Scientific is recalling certain Extractor Pro RX-S Retrieval Balloon Catheters due to a label error that incorrectly states the injection location relative to the balloon. This could cause improper use if the catheter is inserted into the body. Read more at govinfonow.com/recall/73986-boston-scientific-extractor-pro-rx-s-catheter-label-error-injection.
Source Summary by GovInfoNow · govinfonow.com/recall/73986-boston-scientific-extractor-pro-rx-s-catheter-label-error-injection · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2674-2017
Cite this page
“Boston Scientific Extractor Pro RX-S Catheter Label Error: Injection Location Misstated.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73986-boston-scientific-extractor-pro-rx-s-catheter-label-error-injection. Based on FDA recall #Z-2674-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2674-2017%22&limit=1).
Why it’s dangerous
The label incorrectly states whether the injection location is above or below the balloon. This could lead to improper placement during medical procedures if the catheter is inserted into the body.
Who’s affected
Patients using the catheter for medical procedures who may have the incorrect labeling. Healthcare providers administering the catheter are most at risk of improper use.
How to tell if you have this one
Check for UPN M00547340 and lot number 19343209 on the catheter packaging. The catheter expires June 3, 2018.
- Brand
Boston Scientific- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2673-2017 | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300; Lot Number: 19343203 Exp.: 6/30/2018 | 39 units |
| Z-2674-2017 | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340; Lot Number: 19343209 Exp: 6/3 0/2018 | 32 units |
What to do — step by step
Check Label
Verify the UPN number M00547340 and lot number 19343209 on the catheter packaging.
Where it went and when
Where it was distributed
Distributed in Michigan and Missouri, and outside the U.S.
FDA distribution: “MI, MO Foreign: Austria France Great Britain Italy Spain Sweden” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Michigan, Missouri.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-2674-2017 (June 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2674-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.