Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable tissue stabi

FDA device recall Z-0134-2011 · posted 2010-11-01 · Terminated

Recall details

Recalling firm

Medtronic Perfusion Systems

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

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

DWS

Quantity affected

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, I

Date initiated

2010-09-13

Date posted

2010-11-01

Date terminated

2012-04-16

Location

Brooklyn Park, MN