FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
- Recall number
- Z-1456-2017
- Recalling firm
- Maquet Cardiovascular, LLC
- Product
- VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
- Status
- Terminated
- Initiated
- 2017-01-27
- Posted
- not on file
- Terminated
- 2018-04-12
- Reason
- Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.
- Root cause
- Under Investigation by firm
- Action
- Maquet Inc. issued an Urgent Removal Correction Notice letter dated January 27, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory for affected device. Remove and keep it in a secure location to preclude being used. Customers were asked to complete the Medical Device Removal Response Form and return to Maquet by e-mailing a scanned copy to HemoproPower@getinge.com or by faxing the form to 1-973-629-1518.
- Quantity
- 4283 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- 25126012, 25126080, 25126250, 25126375, 25126542, 25126659, 25128301, 25128602, 25128820, 25128905, 25129016, 25129155, 25129199, 25129239, 25129286, 25129335, 25129416, 25129513
- 510(k) numbers
- ["K153194"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2242352
- Firm city
- Wayne
- 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