AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect
AngioDynamics is recalling 8 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended guidewire.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 defect that prevents the intended use of the product (inability to accept the guidewire), representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
AngioDynamics Inc. is recalling 8 units of the NAMIC Convenience Kit Holyoke Hospital Special Procedure Kit (Catalog No. 60080094, UPN Product No. H749600800941). The affected units are from Batch/Lot 4925662 with a Use By date of 2017-02. These kits were distributed nationwide in California, Illinois, Massachusetts, South Carolina, and Texas.
The recall was initiated because the inner lumen of the needles in the affected lot does not meet the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038-inch guidewire as intended, with some inner lumens found to be 0.036 inches. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel before sliding the catheter over the guidewire.
Healthcare facilities and consumers who have these specific kits should stop using them and contact AngioDynamics Inc. for further instructions on return or replacement.
The recalled product
- Product
- NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter…
- Manufacturer
- AngioDynamics Inc.
- Affected units
- 8
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 (1)
- Batch/Lo. 4925662 Use By 2017-02
Distribution
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
Same manufacturer · AngioDynamics Inc.
See all →- HighAngiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Cobra Non-Braided Manufacturing Defect
FDA (Devices) · 2026-04-29
- HighAccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Pigtail Non-Braided Guidewire Passage Defect
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall
FDA (Devices) · 2026-04-29
Same hazard · device defect
See all →- SevereBard Access Systems Recalls Power-Trialysis Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
Similar recalls
- ModerateNAMIC Fluid Management Convenience Kits Recalled for Assembly Defect
FDA (Devices) · 2018-04-25
- ModerateAngiodynamics 5F Micro-Introducer Kits Recalled for Incorrect Device Packaging
FDA (Devices) · 2020-11-11
- HighAngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk
FDA (Devices) · 2016-12-28
- HighNavilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
FDA (Devices) · 2015-03-04
- ModerateGuidewire Introducer Sheath from Angiodynamics Recalled for Manufacturing Defect
FDA (Devices) · 2024-03-27
- SevereAngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-04-28