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VASOVIEW 7xB Endoscopic Vessel Harvesting System recallZ-3271-2011 · Maquet Cardiovascular, LLC · initiated Dec 17, 2009

Terminated All recalls posted in September 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-3271-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 17, 2009
Posted by the FDA
Sep 20, 2011
Recalling firm
Maquet Cardiovascular, LLC
Quantity
177 units
Product code
GEI
FDA submissions
K041981
Distribution
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.

Product description

VASOVIEW 7xB 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.

Code information (models, lots, serial numbers)

Part number: VH-3200; Lot # 9092371, Exp 8/31/2010; Lot # 9092571, Exp 8/31/2010 - never shipped.

Other devices under the same FDA submission

2 devices cleared under K041981 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 59865).

Sources and updates

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