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Class 1 Device Recall Medtronic Octopus Nuvo Tissue Stabilizer |
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Date Initiated by Firm |
September 13, 2010 |
Date Posted |
November 01, 2010 |
Recall Status1 |
Terminated 3 on April 16, 2012 |
Recall Number |
Z-0134-2011 |
Recall Event ID |
56902 |
Product Classification |
Instruments, surgical, cardiovascular - Product Code DWS
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Product |
Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable tissue stabilization system consisting of a rigid shaft, detachable tissue stabilizer headlink and a flexible articulating arm. The device is assembled within the thoracic cavity. Sterilized using ethylene oxide, non pyrogenic, disposable, single use only.
The product is intended to stabilize and minimize the motion of selected areas of the beating heart during minimally invasive cardiac surgery procedures under direct visualization through a thoracotomy. |
Code Information |
Lot #: 201002P030, 2010030795, 2010032195, 2010032196, 2010032690, 2010033377, 2010040102, 2010040103, 2010040673, 2010041001, 2010041500, 2010061786, 2010062722, 2010071111, 2010081105, 2010081987. |
Recalling Firm/ Manufacturer |
Medtronic Perfusion Systems 7611 Northland Dr N Brooklyn Park MN 55428-1088
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For Additional Information Contact |
763-391-9000
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Manufacturer Reason for Recall |
Medtronic has received reports regarding the Octopus Nuvo Tissue Stabilizer stating that during use, the collet (a component of the device that stabilizes the head link) fractured, thereby causing immediate separation of the head link from the shaft of the device. The resulting potential hazards are that fragments of the collet could fall into the patient's chest cavity and/or damage the heart ti
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FDA Determined Cause 2 |
Component design/selection |
Action |
Medtronic sent an "Urgent Medical Device Recall Notice" dated September 14, 2010, to Risk Managers at each affected account. The letter described the issue, identified affected lot numbers, asked for immediate discontinued use of the device, quarantine all unused devices and to return unused devices to Medtronic CardioVascular, 7611 Northland Drive, Brooklyn Park, MN 55428 and requested a recall certificate be faxed back to Medtronic indicated acknowledgement of the Recall Notice and quantity to be returned.
If you need additional information, please contact Medtronic Cardiovascular Lifeline Technical Services at 877-526-7890, or your local Medtronic sales representative. |
Quantity in Commerce |
571 units |
Distribution |
within the US to: AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI and Washington D.C. OUS to include: Belgium, Canada, Germany, Italy, Poland, Switzerland, United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
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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.
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