AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk
AngioDynamics is recalling 145 boxes of Stiffened Micro-Introducer Kits because the sheath/dilator components may have a rotating luer that detaches 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 risk-of-harm product where a component may detach during use, but the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
AngioDynamics, Inc. is recalling 145 boxes of its Percutaneous Introducer Sets, specifically the 4 F Stiffened Micro-Introducer Kits. The affected products are identified by Item Numbers H787065970655 and H787065970695, and Catalog Numbers REF 06597065 and REF 06597069. These kits are 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 used in these kits, 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, identified by Greatbatch Model Numbers 10904-001 and 10904-002, were included in the packaged AngioDynamics Stiffened Micro-Introducer Kits.
The affected lots are 5066410, 5029429, 5043441, and 5074176. 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. Users should stop using the affected products and contact AngioDynamics for further instructions.
The recalled product
- Product
- ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number…
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 145
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 (4)
- Batch/Lot: 1) 5066410
- 2) 5029429
- 5043441
- 5074176
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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