—#103887

Product

VASOVIEW 6 Endoscopic Vessel Harvesting System Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K041981
Affected lot / code info: Part number: VH-2000; Lot # 9092171, Exp 8/31/2010

Why it was recalled

During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

MAQUET Cardiovascular, LLC, sent an "Urgent Device Removal/Immediate Action Required" letter dated December 17, 2009, to all affected customers. The letter identified the recalled products, the problem, and the actions needed to be taken. The letters asked customers to examine their stocks (inventory) immediately to determine if they had any affected lot numbers and to discontinue dispensing (distributing) the lot. The letter states that customers are to complete the attached Field Action Response form regardless of whether or not the affected products are located in their inventory. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. The letter instructed all users to return all unused affected products to MAQUET. For customer's convenience, all affected products that are returned may be exchanged with other unaffected VASOVIEW Endoscopic Vessel Harvesting System by overnight delivery. Questions should be directed to MAQUET Cardiovascular sales representative or Customer Service at 1-888-880-2874.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution (USA) including the states of: AL, AZ, CA, CT, FL, KS, KY, IL, IN, MI, MO, ND, NY, NV, OH, OK, OR, PA, SC, TN, TX, UT, WA, and WI.

Timeline

Recall initiated: 2009-12-17
Posted by FDA: 2011-09-20
Terminated: 2011-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.