—#124275

Product

Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K052274, K101274
Affected lot / code info: Catalog number VH-3000 (US) Lot numbers 25081686, 25081595, 25081460, 25081204, 25080939, 25080744, 25080418, 25080351, 25080264, 25079982, 25079913, 25073724, 25079449, 25079363, 25079086, 25078931, 25078713, 25078463, 25078291, 25078104, 25077927,25077643, 25077563, 25077123, 25076989, 25076372, 25076371, 25076133, Catalog number VH-3000W (Foreign) Lot numbers 25080938, 25080661, 25080311, 25078777, 25078289, 25078103 and 25077051

Why it was recalled

Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"

Root cause (FDA determination)

Component design/selection

Action the firm took

Maquet Inc. sent an Urgent - Medical Device Recall (Removal) Immediate Action Required Letter dated October 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please examine your inventory immediately to determine if you have any of the affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System (HEMOPRO 1) VH-3000 with the lot number(s), as specified above. The VH-3000 catalog number and lot number are located on the package label. Please remove the affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System and place in a secure location. NOTE: VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System HEMOPRO 1 lot numbers not listed are not affected by this recall and should not be removed. HEMOPRO 2 is not affected by this recall. Your MAQUET Cardiovascular Sales Representative will contact you shortly to assist with the completion of the enclosed Acknowledgement Form (Fax Back Form), the return of any affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System HEMOPRO 1 product and arrange for necessary replacement. We apologize for any inconvenience this may cause. If you have any questions, please contact your local MAQUET Cardiovascular Sales Representative or MAQUET Customer Service at 1-888-880-2874, Monday through Friday, between the hours of 6:00 a.m. and 5:00 p.m. PST. Thank you for your cooperation and immediate assistance.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Brazil, Czech Republic, Denmark, France, Hong Kong, Italy, Middle East, Netherlands, Singapore, Switzerland, and the United Kingdom.

Timeline

Recall initiated: 2013-10-30
Posted by FDA: 2013-12-06
Terminated: 2015-04-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124275. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.