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Serious riskFDA DeviceClass I

Boston Scientific AXIOS stent system recalled for deployment issues

Boston Scientific is recalling certain AXIOS Stents (8mm x 8mm) used in medical procedures because they may not deploy or expand properly. If the stent fails to deploy correctly, additional procedures may be needed to remove it and repair the puncture site.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

  1. If you recently had a procedure using an AXIOS Stent 8mm, contact your doctor immediately.
  2. Provide your doctor with the lot number from your procedure records if available.
  3. Ask your doctor whether your stent was affected and whether follow-up care is needed.
  4. Do not attempt to remove or adjust the stent yourself.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 6 products — see all of them.

Details

Units affected
59 units
Illnesses reported
None reported
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Classification
Class I
Recall number
Z-1160-2026

In the FDA's words

Description
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690; Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site. Material Number (UPN): M00553690; UDI-DI: 191506008093; Lot Numbers: 35960775, 35960777, 35962525, 36100561, 36101748, 36111316, 36154532, 36154533, 36241501, 36251362, 36253016, 36293839, 36301625, 36303192, 36420219, 36425888, 36449561, 36458830, 36461449, 36478580, 36492661, 36495673, 36573597, 36573598, 36573599, 36574152, 36576474, 36584299, 36604665, 36731807, 36731808, 36737997, 36743059, 36743200, 36904231, 36904232, 36904233, 36906587, 36907000, 36907001, 36907032, 37217612, 37217613, 37217614, 37440330, 37495327, 37511242, 37602825, 37602826, 37689946, 37694053, 37694054, 37764851, 37764852, 37995048, 37995049, 37995050, 38025042, 38025043, Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom. Affected quantity: 59 units
Hazard
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

6 products in this recall

Boston Scientific AXIOS stent system recalled for deployment risk

Boston Scientific is recalling six versions of its AXIOS Stent and Electrocautery-Enhanced Delivery System after reports that the stent did not deploy or expand properly. The most likely result is a longer procedure while the device is swapped for a new one. In rare cases, the stent may need to be removed through a second endoscopic or surgical procedure. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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