Lower riskMedical device recall · FDA · Published December 3, 2025
Boston Scientific Coyote Catheters: Inflation/Deflation Issues in Peripheral Vessels
Boston Scientific recalls specific batches of Coyote Over-the-Wire PTA Balloon Dilation Catheters due to potential inflation/deflation difficulties during peripheral vascular procedures. Affected units were manufactured between September 12 and October 13, 2025.
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
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Contact the company
📍Recalling firmBoston Scientific Corporation1 Scimed Pl · Maple Grove, MN 55311-1565
“Boston Scientific Coyote Catheters: Inflation/Deflation Issues in Peripheral Vessels.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50549-boston-scientific-coyote-catheters-inflation-deflation-issues-in-peripheral-vessels. Based on FDA recall #Z-1042-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1042-2026%22&limit=1).
The FDA announced on Dec. 3, 2025, that Boston Scientific Corporation is recalling certain batches of Coyote OVER-THE-WIRE PTA Balloon Dilation Catheters due to potential inflation or deflation difficulties during use. The agency issued recall number Z-1042-2026 for the Class II voluntary removal.
Model No. REF H74939186251210 (2.5mm x120mm, 150 cm)
Model No. REF H74939186351210 (3.5mm x120mm, 150 cm)
UPC 08714729796527, Batch Number 37370117
UPC 08714729796756, Batch Number 37416646
Manufactured: 12Sep2025 through 13Oct2025
The hazard
An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate or deflate. This issue is limited to Coyote OTW batches manufactured from Sept. 12, 2025, through Oct. 13, 2025.
Context
GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent brand recalls include the Aug. 24, 2026, Imager II Angiographic Catheters Recall for tip fracture risk and the Aug. 6, 2026, LUX-Dx Cardiac Monitor System Recall for delayed AF burden alerts. Other recent recalls of similar products include the May 4, 2026, Medline Urethral Catheters recall for surface issues and the Feb. 13, 2026, Merit Medical BioFlo DuraMax Catheter recall for a design defect.
How to tell if you have this one
Check for the model numbers REF H74939186251210 (2.5mm x120mm) or REF H74939186351210 (3.5mm x120mm). Affected units were manufactured between September 12 and October 13, 2025, with specific batch numbers and expiration dates.
Brand
Boston Scientific
Product
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the model number and batch date from the product label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Massachusetts, Minnesota, New York, Ohio, Texas, Virginia, West Virginia.
Recall timeline
FDA published this recall 49 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-1042-2026 (December 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1042-2026 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.