FDA Medical Device Recalls (openFDA)
Terumo Medical Corp: Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
- Recall number
- Z-2337-2018
- Recalling firm
- Terumo Medical Corp
- Product
- Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
- Status
- Terminated
- Initiated
- 2018-04-09
- Posted
- not on file
- Terminated
- 2019-04-19
- Reason
- 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
- 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
- 240
- Distribution
- Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.
- Lot, serial or model codes
- 5980075, 5980077
- 510(k) numbers
- not on file
- PMA numbers
- ["P930038"]
- Product code
- MGB
- Firm FEI
- 2243441
- Firm city
- Somerset
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28