Z-2337-2018Class II

Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135

Name: Z-2337-2018 Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Creator: Terumo Medical Corp
Published: 2018-04-09
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2018-04-09 / Terminated / root cause: sterility

FDA source

Terumo Medical Corp began a recall of Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135 on 2018-04-09. FDA classified it as Class II and gives the reason as "Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2337-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-09
Posted: 2018-06-29
Terminated: 2019-04-19
Recalling firm: Terumo Medical Corp.
Product: Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Product code: MGB Device, Hemostasis, Vascular
Reason for recall: Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.
Root cause tag: sterility
FDA root cause: Release of Material/Component prior to receiving test results
Action: On April 9, 2018, the firm sent Urgent Voluntary Medical Device Recall letters and Inventory Confirmation Forms to customers via FedEx. The letter described the product issue. Customers were asked to: 1. Review your Angio-Seal Evolution inventory immediately to identify and isolate affected inventory in order to prevent future use. 2. Your Terumo Territory Manager will visit your facility to confirm product inventory and assist you in completing the enclosed Recall Acknowledgement/ Inventory Confirmation Form. This required documentation, along with the enclosed Fed-Ex product shipment labels will facilitate your return of affected Angio-Seal Evolution product to Terumo Medical Corporation.
Quantity in commerce: 240
Distribution: Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.
Product codes and lots: 5980075, 5980077

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2337-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2337-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-06-29

Product code MGB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)