Z-1456-2017Class II

Vasoview Hemopro Vh-3500 Endoscopic Vessel Harvesting System

Name: Z-1456-2017 Vasoview Hemopro Vh-3500 Endoscopic Vessel Harvesting System
Creator: Maquet Cardiovascular, LLC
Published: 2017-01-27
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2017-01-27 / Terminated

FDA source

Maquet Cardiovascular, LLC began a recall of 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... on 2017-01-27. FDA classified it as Class II and gives the reason as "Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1456-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-27
Posted: 2017-03-14
Terminated: 2018-04-12
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.
FDA 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 [email protected] or by faxing the form to 1-973-629-1518.
Quantity in commerce: 4283 units
Distribution: US Nationwide Distribution
Product codes and lots: 25126012, 25126080, 25126250, 25126375, 25126542, 25126659, 25128301, 25128602, 25128820, 25128905, 25129016, 25129155, 25129199, 25129239, 25129286, 25129335, 25129416, 25129513

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1456-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1456-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13

Product code GEI

K153194Class IIVASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC / cleared 2016-04-19

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)