Strata Valves (2017-03-13)

Starting date:

March 13, 2017

Posting date:

March 31, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-62844

• Reason
• Affected products

Affected Products

1. Strata Valve
2. Strata Valve With Bioglide
3. Strata Shunt Assembly
4. Strata Unitized Shunt Kit
5. Strata Shunt Assembly With Distal Catheter
6. Strata Snap Shunt Assembly
7. Strata II Valve
8. Strata II Valve With Bioglide
9. Strata II Unitized Shunt Kit
10. Strata II Unitized Shunt Kit With Bioglide
11. Strata II Shunt Assembly
12. Strat II Snap Shunt Assembly
13. Strata II Shunt Assembly With Bioglide
14. Strata II Snap Shunt Assembly With Bioglide
15. Strata NSC Lumboperitoneal Shunt Kit
16. Strata Burr Hole Shunt Assembly
17. Strata NSC Burr Hole Shunt Assembly
18. Strata Burr Hole Valve
19. Strata NSC Burr Hole Valve

Reason

The adjustable mechanism in the Strata device allows the physician to non-invasively adjust the valve's pressure/performance level using a magnetic adjustment tool included with the strata adjustment kit or with the Stratavarius System. Accumulation of biological debris within the valve adjustment mechanism may inhibit the free rotation of the valve magnet when exposed to 3T MRI and may become reverse polarised. This may result in discrepancies between the pressure level readings on the strata indicator tool or Stratavarius System.

Affected products