AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk
AngioDynamics is recalling 751 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 injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
AngioDynamics, Inc. is recalling 751 units of its Stiffened Micro-Introducer Kits. The recall involves specific 4 F Stiffened Micro-Introducer Kits distributed nationwide to 25 states. The affected products include Item Numbers H787065970505, H787065970525, and H787065970545.
The recall is due to a defect in the 4F and 5F sheath/dilator components manufactured by Greatbatch Medical. Greatbatch determined that the rotating luer on these components has the potential to detach from the dilator hub during use. AngioDynamics confirmed that these affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) were included in the packaged AngioDynamics kits.
The affected products are indicated for the percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick. The source text does not specify specific instructions for consumers or healthcare providers regarding the immediate handling of these devices.
The recalled product
- Product
- ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970525, Catalog…
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 751
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 (11)
- Batch/Lot: 1) 5030257
- 5046424
- 5063169
- 5073449
- 5074171
- 2) 5031722
- 5043440
- 5061392
- 5066414
- 3) 5037972
- 5046429
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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