The Recall Desk
HighFDA (Devices)·Z-0775-2017·Announced 2016-12-28

AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk

AngioDynamics is recalling 996 boxes of Stiffened Micro-Introducer Kits because the rotating luer on the included sheath/dilator components may detach 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 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 criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

AngioDynamics, Inc. is recalling 996 boxes of its Stiffened Micro-Introducer Kits. The affected products are the 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, and 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG. 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 (Greatbatch Model Numbers 10904-001 and 10904-002) were included in the packaged kits.

The affected 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. Specific lot numbers are listed in the agency's recall record. Users should stop using these products and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog N
Manufacturer
Angiodynamics, Inc.
Category
Medical Device — Vascular Access
Hazard
Affected units
996

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 (18)

  • Batch/Lot: 1) 5030537
  • 5037976
  • 5043444
  • 5059984
  • 5066413
  • 2) 5024545
  • 5031723
  • 5038659
  • 5042534
  • 5065538
  • 5071294
  • 5076428
  • 5082169
  • 3) 5022318
  • 5032456
  • 5034279
  • 5081986
  • 5082446

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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