—#152788

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.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K153194
Affected lot / code info: 25126012, 25126080, 25126250, 25126375, 25126542, 25126659, 25128301, 25128602, 25128820, 25128905, 25129016, 25129155, 25129199, 25129239, 25129286, 25129335, 25129416, 25129513

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2017-01-27
Terminated: 2018-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152788. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.