Z-0378-2014Class II

Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent...

Name: Z-0378-2014 Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent...
Creator: Mizuho America, Inc.
Published: 2013-10-10
License: https://open.fda.gov/license/

Mizuho America, Inc. / initiated 2013-10-10 / Terminated / root cause: manufacturing process

FDA source

Mizuho America, Inc. began a recall of Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and... on 2013-10-10. FDA classified it as Class II and gives the reason as "Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0378-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-10
Posted: 2013-11-22
Terminated: 2014-01-13
Recalling firm: Mizuho America, Inc.
Product: Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
Product code: HCH Clip, Aneurysm
Reason for recall: Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Mizuho sent a Product Recall Notice dated October 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to verify serial number before opening package and conduct a physical examination of the product for discolored Clips from the affected lots. Customers were also asked to fill out the Confirmation of User Receipt, and return to Misuho America. If customers should find affed clips they were instructed to quarantine them an call Mizuho America Customer Service at 800-699-2547 for return instructions. The Clips will be exchanged at no charge. Customers were also asked to ensure that all appropriate persons within the Hospital have been notified of the Recall Notice. For questions regarding this recall call 510-324-4500, ext 122.
Quantity in commerce: 35
Distribution: Nationwide Distribution
Product codes and lots: Product Code 17-001-58; Lot No. 29JY

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0378-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0377-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-22
Z-0378-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-22

Product code HCH

K990202Class IISugita Titanium Aneurysm ClipMizuho America, Inc. / cleared 1999-06-04

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)