AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Component Defect
AngioDynamics is recalling 80 boxes of Stiffened Micro-Introducer Kits because a component may detach 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 that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AngioDynamics, Inc. is recalling 80 boxes of its Stiffened Micro-Introducer Kits. The affected products are the 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG (Item Number H787065970465) and the 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG (Item Number H787065970485). These kits are indicated for the percutaneous introduction of guidewires or catheters into the vascular system.
The recall is being conducted because Greatbatch Medical, the manufacturer of the 4F and 5F sheath/dilator components included in these kits, determined that the rotating luer has the potential to detach from the dilator hub during use. AngioDynamics confirmed that the affected Greatbatch sheath/dilators (Model Numbers 10904-001 and 10904-002) were included in the packaged AngioDynamics kits.
The affected lots are 5074174, 5043439, 5061389, and 5067424. The products were distributed nationwide to facilities in 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 kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG, Item Number H787065970485, Catalog…
- Manufacturer
- Angiodynamics, Inc.
- Affected units
- 80
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 (3)
- Batch/Lot: 1) 5074174
- 2) 5043439
- 5061389 & 5067424
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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