Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF Recalled by Terumo Medical Corporation Due to Terumo Medical is initiating this recall due to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Medical Corporation directly.
Affected Products
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
Quantity: 1,370,995 eaches have been distributed to the field
Why Was This Recalled?
Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Medical Corporation
Terumo Medical Corporation has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report