Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
ANGIODYNAMICS 4F Stiffened Micro-Introducer Recalled by Angiodynamics, Inc. Due to Greatbatch Medical the manufacturer of the 4F and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Angiodynamics, Inc. directly.
Affected Products
ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
Quantity: 4 boxes
Why Was This Recalled?
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Angiodynamics, Inc.
Angiodynamics, Inc. has 74 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report