AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk
AngioDynamics is recalling 4F Stiffened Micro-Introducer Kits because the sheath/dilator components may have a rotating luer that detaches from the 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect (luer detachment) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AngioDynamics, Inc. is recalling 4 boxes of the 4F Stiffened Micro-Introducer (Item Number H787065971035, Catalog No. REF 06597103). The product is indicated for the percutaneous introduction of a guidewire or catheter 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 product was 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. The specific batch/lot number is 5034283.
The recalled product
- Product
- 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
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 4
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 (1)
- Batch/Lot: 1) 5034283
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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