Atrium Medical Corporation
40 Continental Blvd, Merrimack, NH, US
Registered product codes
9 product codes
Recent MDR events
6,037 on file
- ADVANTA SLIDER GDSJul 31, 2026Injury3011175548-2026-000008
- ADVANTA SLIDER GDSJul 31, 2026Injury3011175548-2026-000009
- Advanta V12 covered stent sys, 9X38X80Jul 28, 2026Malfunction3011175548-2026-000008
- OASISJul 28, 2026Malfunction3011175548-2026-000008
- OasisJul 28, 2026Malfunction3011175548-2026-000008
- OasisJul 28, 2026Malfunction3011175548-2026-000008
- OASISJul 16, 2026Malfunction3011175548-2026-000008
- ICAST COVERED STENT SYSTEM, 5MM X 32MM X 120CMJul 10, 2026Malfunction3011175548-2026-000008
- ADVANTA SLIDER GDSJul 3, 2026Malfunction3011175548-2026-000008
- ICAST COVERED STENT SYSTEM, 5MMX22MMX80CMJul 2, 2026Malfunction3011175548-2026-000007
Recalls
177 on file
- Open, ClassifiedOct 7, 2024
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
View FDA record ↗ - Open, ClassifiedJun 4, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
View FDA record ↗ - Open, ClassifiedJun 4, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
View FDA record ↗ - Open, ClassifiedJun 4, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
View FDA record ↗ - Open, ClassifiedJun 4, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
View FDA record ↗ - Open, ClassifiedJun 4, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
View FDA record ↗ - Open, ClassifiedJun 4, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
View FDA record ↗ - Open, ClassifiedJun 4, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
View FDA record ↗ - Open, ClassifiedJun 4, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
View FDA record ↗ - Open, ClassifiedJun 4, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
View FDA record ↗
Compliance history
Matched by FEI 3011175548.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 26, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Nov 26, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗21 CFR 803.50(a)(1)Report of Death or Serious Injury
121 CFR 803.50(a)(2)Individual Report of Malfunction
121 CFR 820.30(f)Design verification - output does not meet input requirement
121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
121 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
1
- 21 CFR 803.50(a)(1)Nov 26, 2024
Report of Death or Serious Injury
- 21 CFR 803.50(a)(2)Nov 26, 2024
Individual Report of Malfunction
- 21 CFR 820.30(f)Nov 26, 2024
Design verification - output does not meet input requirement
- 21 CFR 820.70(c)Nov 26, 2024
Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Nov 26, 2024
Contamination control, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nov 26, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Nov 26, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(c)Nov 26, 2024
Investigation of device failures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.