Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system
Medical device recall Z-2273-2025. Published in FDA’s Enforcement Report on Aug 20, 2025.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 20, 2025. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 26,570 (1,333 US; 25,174 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL 6.0-22; H749391508210 CAROTID WALLSTENT MONORAIL 8.0-21; H749391508290 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647010 CAROTID WALLSTENT MONORAIL 6.0-22; H965SCH647070 CAROTID WALLSTENT MONORAIL 8.0-21; H965SCH647080 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647090 CAROTID WALLSTENT MONORAIL 8.0-36; H965SCH647120 CAROTID WALLSTENT MONORAIL 10.0-24; H965SCH647130 CAROTID WALLSTENT MONORAIL 10.0-31; H965SCH647140 CAROTID WALLSTENT MONORAIL 10.0-37; M001719000 CAROTID WALLSTENT MR 6X22 5F 135CM; M001719010 CAROTID WALLSTENT MR 8X21 5F 135CM; M001719020 CAROTID WALLSTENT MR 8X29 5F 135CM; M001719030 CAROTID WALLSTENT MR 8X36 5F 135CM; M001719040 CAROTID WALLSTENT MR 10X24 5.9F 135CM; M001719050 CAROTID WALLSTENT MR 10X31 5.9F 135CM; M001719060 CAROTID WALLSTENT MR 10X37 5.9F 135CM;
26,570 (1,333 US; 25,174 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1. H7493915010240 UDI-DI 08714729781097 Batches 35277608 35315983 35315984 35315985 35380314 35452835 35452836 35514614 35551688 35551689 35664523 35664524 35750157 35750158 35750159 35750400 35879409 35879410 35921915 35922951 35926817…
Every code shown here, 1,995 characters
1. H7493915010240 UDI-DI 08714729781097 Batches 35277608 35315983 35315984 35315985 35380314 35452835 35452836 35514614 35551688 35551689 35664523 35664524 35750157 35750158 35750159 35750400 35879409 35879410 35921915 35922951 35926817 35926818 35942366 36056965 36058841 36058842 36058843 36096638 36121883 36138618 36138619 36138801 36138802 36138803 36159671 36195057 36195058 36195059 36195360 36205167 36209423 36214805 36214806 36256192 36322725 36348207 36348208 36348209 36498256 36588496 36607566 36711321; 2. H7493915010310 UDI-DI 08714729781110 Batches 35294379 35294540 35295922 35330503 35330504 35336132 35347263 35382292 35383351 35383352 35453002 35461487 35461488 35528579 35529200 35628964 35628965 35628966 35641995 35662047 35664484 35664485 35750401 35750402 35750403 35750404 35750405 35750406 35750407 35890012 35893584 35893585 35894358 35894359 35938922 35938923 35938924 35938925 35938926 36002641 36002642 36063291 36063292 36105446 36133161 36134808 36144148 36148535 36154091 36154092 36154093 36154094 36154095 36169871 36169872 36197809 36197810 36197811 36197812 36197813 36200118 36202762 36204350 36212466 36212467 36212468 36256193 36256194 36256195 36357711 36357712 36368143 36368144 36368145 36516036 36603362 36603363 36642784 36683543 36688775 36811476 36811477 36818953; 3. H749391506220 UDI-DI 08714729781158 Batches 35582211 35750408 35947814 35947815 35950476 36009906 36292862 36397124 36652844; 4. H749391508210 UDI-DI 08714729781172 Batches 35343574 35438658 35487375 35567637 35652700 35656388 35750409 35757024 35873346 35873347 35901381 35901382 35999854 35999855 35999856 36246587 36246588 36246589 36292863 36306518 36376412 36410418 36410419 36412851 36479267 36565560 36636529 36724350 36777341 5. H749391508290 UDI-DI 08714729781196 Batches 35339488 35375416 35375417 35462381 35529285 35529286 35617101 35617102 35618276 35662042 35662043 35749222 35750156 35750410 35750411 35750412 35750413 35771618 35944023 35944024 35946987 35946988…
FDA’s list runs to 26,044 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Domestic US Nationwide distribution including Puerto Rico. International distribution worldwide.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 7, 2025.
- FDA classified it on Aug 8, 2025.
- FDA’s Enforcement Report published it on Aug 20, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Boston Scientific Corporation, of Maple Grove, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 26,044 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.