Na 10B42R

• • Terminated Z-2736-2015 FDA Class II ·initiated 18 Aug 2015

  Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.

• • Terminated Z-1000-2014 FDA Class II ·initiated 30 Jan 2014

  Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

• • Terminated Z-2104-2013 FDA Class II ·initiated 17 Jul 2013

  Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.

• • Terminated Z-0618-2013 FDA Class II ·initiated 19 Nov 2012 ·on shared 510(k) K800178

  Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.

• • Terminated Z-0814-2012 FDA Unclassified (pre-2012) ·initiated 14 Dec 2011

  Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p

• • Terminated Z-1424-2009 FDA Unclassified (pre-2012) ·initiated 25 Feb 2009

  Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. Use of the product may cause serious health consequences from potential sepsis/infection and the associated remote risk of death.

• • Terminated Z-1227-2007 FDA Unclassified (pre-2012) ·initiated 1 Aug 2007

  Medtronic Custom Tubing Packs might have open header bag seals.

• • Terminated Z-0583-2007 FDA Unclassified (pre-2012) ·initiated 2 Jan 2007

  One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.

• • Terminated Z-0340-2007 FDA Unclassified (pre-2012) ·initiated 13 Sep 2006

  An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.

• • Terminated Z-0808-05 FDA Unclassified (pre-2012) ·initiated 25 Mar 2005

  Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly & had been sterilized, the ruptured seal breaches the sterility barrier for the package.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Generic Name

Cardiopulmonary bypass system blood tubing set

Model / Reference

10B42R

Primary DI / UDI-DI

00763000014124

510(k) Number

K800178 ↗

FDA Product Code

DWE

GMDN Term

Cardiopulmonary bypass system blood tubing set

Device Class

Class II

Regulation Number

870.4390

GUDID distribution status

In Commercial Distribution

Category: Cardiopulmonary bypass system blood tubing set

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