The Recall Desk
HighFDA (Devices)·Z-0777-2017·Announced 2016-12-28

AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk

AngioDynamics is recalling 7 boxes of Stiffened Micro-Introducer Kits because the rotating luer on the included sheath/dilator components may detach from the hub during use.

What this means for you

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 is classified as FDA Class II, and the hazard involves a component detaching during a vascular procedure, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

AngioDynamics, Inc. is recalling 7 boxes of AngioDynamics Percutaneous Introducer Sets, specifically the 5 F Stiffened Micro-Introducer Kits. The affected products are identified by Item Numbers H787065970685 and H787065970705, and Catalog Numbers REF 06597068 and REF 06597070. 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 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 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 5034280, 5067423, 5061461, and 5070972. 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. Healthcare providers should stop using the affected kits and contact AngioDynamics for instructions on returning the products.

The recalled product

Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705,
Manufacturer
Angiodynamics, Inc.
Category
Medical Device — Vascular Access
Hazard
Affected units
7

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) 5034280
  • 5067423
  • 2) 5061461
  • 5070972

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

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.

See all 7 products in this recall →

Related recalls

Same manufacturer · Angiodynamics, Inc.

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Same hazard · component detachment

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