—#94892

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.

FDA product code: DWS — Instruments, Surgical, Cardiovascular
Device class: Class 1
Medical specialty: Cardiovascular
Affected lot / code info: Lot #: 201002P030, 2010030795, 2010032195, 2010032196, 2010032690, 2010033377, 2010040102, 2010040103, 2010040673, 2010041001, 2010041500, 2010061786, 2010062722, 2010071111, 2010081105, 2010081987.

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-09-13
Posted by FDA: 2010-11-01
Terminated: 2012-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94892. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.