Z-0134-2011

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

Name: Z-0134-2011 Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable...
Creator: Medtronic Perfusion Systems
Published: 2010-09-13
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2010-09-13 / Terminated / root cause: design

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable tissue stabilization system consisting of a rigid... on 2010-09-13. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0134-2011
Status: Terminated
Initiated: 2010-09-13
Posted: 2010-11-01
Terminated: 2012-04-16
Recalling firm: Medtronic Perfusion Systems
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.
Product code: DWS Instruments, Surgical, Cardiovascular
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
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Lot #: 201002P030, 2010030795, 2010032195, 2010032196, 2010032690, 2010033377, 2010040102, 2010040103, 2010040673, 2010041001, 2010041500, 2010061786, 2010062722, 2010071111, 2010081105, 2010081987.

Product code DWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)