Terumo Recalls Pinnacle Introducer Sheaths Due to Valve Leakage
Terumo Medical Corporation is recalling Pinnacle Introducer Sheaths due to a manufacturing issue causing valve leakage, which poses a risk of incremental blood loss.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (blood loss) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Terumo Medical Corporation is recalling specific Pinnacle Introducer Sheaths, including the Pinnacle Precision Access System Sheath, Pinnacle TIF Tip Introducer Sheath, and Pinnacle R/O II Radiopaque Marker Introducer Sheath. The recall is being initiated due to complaints of valve leakage related to a manufacturing issue.
The affected devices were distributed nationwide, with a total of 1,370,995 units in the field. If these introducer sheaths are used, there is a possible risk of incremental blood loss through the valve.
Healthcare providers and facilities should stop using the affected devices and contact Terumo Medical Corporation for further instructions on the recall process.
The recalled product
- Product
- PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
- Manufacturer
- Terumo Medical Corporation
- Hazard
- Affected units
- 1,370,995
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Please see Attachment 3
Distribution
Distributed nationwide across the United States.
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