Use cautionMedical device recall · FDA · Published February 20, 2024
Boston Scientific iSLEEVE Expandable Introducer Set Recall: Hemostatic Valve Leak Risk
Boston Scientific recalls specific batches of iSLEEVE 14F Expandable Introducer Sets due to reported hemostatic valve leaks that could cause bleeding during vascular procedures.
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
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Contact the company
📍Recalling firmBoston Scientific Corporation1 Scimed Pl · Maple Grove, MN 55311-1565
“Boston Scientific iSLEEVE Expandable Introducer Set Recall: Hemostatic Valve Leak Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56138-boston-scientific-isleeve-expandable-introducer-set-recall-hemostatic-valve-leak. Based on FDA recall #Z-1390-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1390-2024%22&limit=1).
The FDA announced on Feb. 20, 2024, that Boston Scientific Corporation is recalling specific batches of the iSLEEVE EXPANDABLE Introducer Set due to a hemostatic valve leak hazard. The agency issued recall number Z-1390-2024 for the Class II device.
How to tell if you have it
Brand: Boston Scientific
Product: iSLEEVE EXPANDABLE Introducer Set REF H74939349140
The recall addresses complaints associated with a hemostatic valve leak in the iSLEEVE EXPANDABLE Introducer Set. The device facilitates femoral access to the vascular system.
Context
GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls of similar products include Abiomed Heart Pump Kit Recall (June 11, 2026) and Hamilton Medical IntelliCuff Recall (May 22, 2026).
How to tell if you have this one
Check for the product name 'iSLEEVE EXPANDABLE Introducer Set' with the specific batch numbers listed in the recall notice. The product is sold with the GTIN 08714729950660 and the batch numbers provided in the recall.
Brand
Boston Scientific
Product
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the batch numbers listed in the recall: 31368041, 31390084, 31390088, and other specific batch numbers provided in the notice.
Contact Manufacturer
Reach out to Boston Scientific Corporation directly for further assistance or to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 43 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-1390-2024 (February 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1390-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.