Z-3271-2011

VASOVIEW 7xB Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, LLC; 170 Baytech...

Name: Z-3271-2011 VASOVIEW 7xB Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, LLC; 170 Baytech...
Creator: Maquet Cardiovascular, LLC
Published: 2009-12-17
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2009-12-17 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular, LLC began a recall of VASOVIEW 7xB Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. Product Usage: Endoscopic... on 2009-12-17. The reason FDA records is "During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3271-2011
Status: Terminated
Initiated: 2009-12-17
Posted: 2011-09-20
Terminated: 2011-09-21
Recalling firm: Maquet Cardiovascular LLC
Product: 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 177 units
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 codes and lots: Part number: VH-3200; Lot # 9092371, Exp 8/31/2010; Lot # 9092571, Exp 8/31/2010 - never shipped.

Product code GEI

K041981Class IIGuidant Vasoview 6 Harvesting Cannula, Model Vh-2000; Guidant Vasoview 6 Accessory Pack, Model Vh-2004Guidant Corporation / cleared 2004-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)