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U.S. Department of Health and Human Services

Class 2 Device Recall PINNACLE Introducer Sheath

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 Class 2 Device Recall PINNACLE Introducer Sheathsee related information
Date Initiated by FirmMarch 16, 2016
Date PostedSeptember 06, 2016
Recall Status1 Terminated 3 on January 27, 2017
Recall NumberZ-2738-2016
Recall Event ID 73833
510(K)NumberK111606 
Product Classification Introducer, catheter - Product Code DYB
ProductPINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath
Code Information Please see Attachment 3
FEI Number 1118880
Recalling Firm/
Manufacturer		 Terumo Medical Corporation
950 Elkton Blvd
Elkton MD 21921-5322
For Additional Information Contact
410-392-7226
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionTerumo 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 Commerce1,370,995 eaches have been distributed to the field
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DYB
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