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Recall Observatory FDA recall evidence

Device product

PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath

Z-2738-2016

March 16, 2016

Class II

Product summary

Firm
Terumo Medical Corporation
Event
Event 73833
Status
Terminated
Classification
Class II
Quantity
1,370,995 eaches have been distributed to the field
Official record key
device-enforcement:Z-2738-2016

Official wording

Reason: 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.

Code information: Please see Attachment 3

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.