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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet

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  Class 2 Device Recall Maquet see related information
Date Initiated by Firm January 27, 2017
Create Date March 14, 2017
Recall Status1 Terminated 3 on April 12, 2018
Recall Number Z-1456-2017
Recall Event ID 76326
510(K)Number K153194  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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.
Code Information 25126012, 25126080, 25126250, 25126375, 25126542, 25126659, 25128301, 25128602, 25128820, 25128905, 25129016, 25129155, 25129199, 25129239, 25129286, 25129335, 25129416, 25129513 
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact
888-627-8383
Manufacturer 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 Determined
Cause 2		 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 in Commerce 4283 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = MAQUET CARDIOVASCULAR, LLC
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