FDA Medical Device Recalls (openFDA)
CTS, Inc. dba Guidant Cardiac Surgery: Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Number: VH-2000, Product is manufactured and distributed by Maquet Corporation San Jose, CA
- Recall number
- Z-0614-2011
- Recalling firm
- CTS, Inc. dba Guidant Cardiac Surgery
- Product
- Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Number: VH-2000, Product is manufactured and distributed by Maquet Corporation San Jose, CA
- Status
- Terminated
- Initiated
- 2009-02-05
- Posted
- 2010-12-13
- Terminated
- 2011-01-19
- Reason
- Sterility may be compromised by a loss of package integrity.
- Root cause
- Packaging
- Action
- Maquet issued an Urgent Device Removal letter dated February 5, 2009 to customers, explaining the reason for the recall and requesting the product be returned for replacement. Customers were instructed to examine their inventory and discontinue distribution and use of the affected devices. Customers also were requested to complete and return a Field Action Response Form. Maquet can be contacted at 888-880-2874 concerning this recall.
- Quantity
- not on file
- Distribution
- Distribution: Nationwide and Internationally.
- Lot, serial or model codes
- Affected Lot Number Range: 8030373 to 8112071
- 510(k) numbers
- ["K030512"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3000719698
- Firm city
- San Jose
- Firm state
- CA
- 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