Z-2738-2016Class II

PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath...

Name: Z-2738-2016 PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath...
Creator: Terumo Medical Corporation
Published: 2016-03-16
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2016-03-16 / Terminated / root cause: design

FDA source

Terumo Medical Corporation began a recall of PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath on 2016-03-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2738-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-16
Posted: 2016-09-06
Terminated: 2017-01-27
Recalling firm: Terumo Medical Corp.
Product: PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath
Product code: DYB Introducer, Catheter
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Terumo sent an Urgent Product Recall Bulletin dated March 7, 2016, to all affected customers. All affected customers will be notified regarding the required recall actions (stop using/quarantine the affected products). TMC will strive for 100% verification to confirm that all customers have acknowledged the recall. Follow-up communication is being sent specifying the mechanisms to be used for labeling and returning the involved product from the customer level. We regret any inconvenience this action may cause your operations and we appreciate your understanding. Please contact us if you need assistance procuring additional inventory. We are committed to continuing to offer products that meet the highest quality standards that you expect from Terumo Medical Corporation. If you have questions or need further information, please call Customer Care at 1-800-888-3786 or contact your local sales representative. For further questions regarding this recall please call (410) 392-7226.
Quantity in commerce: 1,370,995 eaches have been distributed to the field
Distribution: Nationwide Distribution
Product codes and lots: Please see Attachment 3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2738-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2738-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-06

Product code DYB

K111606Class IIPinnacle Precision Access SystemTerumo Medical Corp. / cleared 2011-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)