Lower riskMedical device recall · FDA · Published September 10, 2026
Boston Scientific NaviFlex LW Pusher Recall: Incorrect Guidewire Exit Port
Boston Scientific recalls NaviFlex LW Pusher devices with Material Number M00535030 due to incorrect guidewire exit port. Affected units include specific lot numbers sold nationwide in the US.
Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
“Boston Scientific NaviFlex LW Pusher Recall: Incorrect Guidewire Exit Port.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764690-boston-scientific-corporation-recalls-naviflex-lw-pusher-advx-panc-stent. Based on FDA recall #Z-0143-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0143-2027%22&limit=1).
The FDA announced on September 10, 2026, that Boston Scientific Corporation is recalling NaviFlex LW Pushers due to incorrect manufacturing. The devices feature a guidewire exit port not associated with this configuration.
The device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
Context
GovInfoNow's records show Boston Scientific Corporation has 125 other recalls on record since June 1, 2017. Recent recalls include the August 24, 2026 Imager II Angiographic Catheters Recall for tip fracture risk and the August 6, 2026 LUX-Dx Cardiac Monitor System Recall for delayed AF burden alerts. Other recent recalls of similar products include the March 3, 2026 Soft-Vu Angiographic Catheter Recall, the March 3, 2026 Angiodynamics Soft-Vu Catheter Recall, and the March 3, 2026 Angiodynamics AccuVu Catheter Recall.
How to tell if you have this one
Check for Material Number (UPN) M00535030 on the device. Affected units include specific lot numbers: 38904309, 39017263, and 39365322. These devices were distributed nationwide in the US states listed in the recall.
Brand
Boston Scientific
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Label
Look for Material Number (UPN) M00535030 on the device label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, CA, FL, GA, IL, IN, KY, MD, NC, NH, NM, NY, RI, TX, WA, WI, WV and the countries in TBD.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, New Hampshire, New Mexico, New York, North Carolina, Rhode Island, Texas, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
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-0143-2027 (September 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0143-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 27, 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.