SoloPath Access Systems recall in Canada: Medical device defect
In plain language
This recall involves SoloPath Transfemoral and Re-Collapsible Access Systems sold in Canada. They are being recalled because the tip of the device may dislodge, which could cause a loss of the smooth transition from the tip to the sheath. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Terumo Medical Corporation for more information.
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Affected products
SoloPath Transfemoral Access System
Model: STFI-1435, STFI-1625, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2135
Lot: More than 10 numbers, contact manufacturer.
SoloPath re-Collapsible Access System
Model: SR-1925, SR-1935, SR-2235, SR-2425, SR-2435
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Medical device defect
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: SR-1925, SR-1935, SR-2235, SR-2425, SR-2435, STFI-1435, STFI-1625, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2135
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Medical device defect
What should consumers do?
Stop using the product immediately. Contact Terumo Medical Corporation for more information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Medical device defect
When was this product recalled?
This product was recalled on May 10, 2019.
Is the SoloPath brand affected by this recall?
Yes, SoloPath products are affected by this recall. This recall involves SoloPath Transfemoral and Re-Collapsible Access Systems sold in Canada. They are being recalled because the tip of the device may dislodge, which could cause a loss of the smooth transition from the tip to the sheath. Stop using the product and follow the return steps in the official notice.