AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk
AngioDynamics is recalling 162 boxes of Stiffened Micro-Introducer Kits because the rotating luer may detach from the dilator hub during use.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, and no specific injuries or illnesses are reported in the source text.
Plain-English summary
AngioDynamics, Inc. is recalling 162 boxes of Percutaneous Introducer Sets, specifically the 5 F Stiffened Micro-Introducer Kits. The affected products are identified by Item Numbers H787065970395 and H787065970415, and Catalog Numbers REF 06597039 and REF 06597041. These kits are indicated for the percutaneous introduction of guidewires or catheters into the vascular system following a small 21-gauge needle stick.
The recall was initiated because Greatbatch Medical, the manufacturer of the 4F and 5F sheath/dilator components, determined that the products have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics confirmed that the affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) were included in the packaged AngioDynamics Stiffened Micro-Introducer Kits.
The affected lots are 5046426, 5022317, 5032458, 5040672, 5046428, 5063983, and 5081983. The products were distributed nationwide to Alabama, Arkansas, California, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, Ohio, Oklahoma, South Carolina, New York, Maine, Pennsylvania, Maryland, Virginia, Washington, Wisconsin, West Virginia, Tennessee, and Texas. Healthcare facilities and consumers should stop using these products and contact AngioDynamics for further instructions.
The recalled product
- Product
- ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number…
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 162
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Batch/Lot: 1) 5046426
- 2) 5022317
- 5032458
- 5040672
- 5046428
- 5063983 & 5081983
Distribution
Part of a larger recall action
This product is one of 7 recalled by Angiodynamics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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