The Recall Desk
HighFDA (Devices)·Z-0776-2017·Announced 2016-12-28

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.

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 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 H7
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

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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