Extracorporeal Circuit with Bio-Active Surface

• • Terminated Z-2495-2020 FDA Class II ·initiated 8 Aug 2018

  Affected products failed a sterilization test.

• • Terminated Z-1023-2016 FDA Class III ·initiated 4 Feb 2016 ·on shared 510(k) K891687

  Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.

• • Terminated Z-2736-2015 FDA Class II ·initiated 18 Aug 2015 ·on shared 510(k) K891687

  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-2105-2013 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) K891687

  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-0813-2012 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-1920-2008 FDA Unclassified (pre-2012) ·initiated 9 May 2008

  Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).

• • Terminated Z-1227-2007 FDA Unclassified (pre-2012) ·initiated 1 Aug 2007 ·on shared 510(k) K891687

  Medtronic Custom Tubing Packs might have open header bag seals.

• • Terminated Z-0583-2007 FDA Unclassified (pre-2012) ·initiated 2 Jan 2007 ·on shared 510(k) K891687

  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-1489-04 FDA Unclassified (pre-2012) ·initiated 15 Sep 2004 ·on shared 510(k) K891687

  Spiral tip from DLP VAD cannula may be loose and potentially detach during use.

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

510(k) Number

K891687 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 26mm Diameter Hancock* Trocar Blade and Tip

  Class I

  FDA 510(k) K882479 Active Cleared 18 Jul 1988

• Intersept*prebypass Filter

  Class II

  FDA 510(k) K883086 Active Cleared 16 Sep 1988

• Intersept*crystalloid Cardioplegia Delivery System

  Class II

  FDA 510(k) K883439 Active Cleared 13 Oct 1988

• Intersept* Prebypass Filter

  Class II

  FDA 510(k) K884244 Active Cleared 5 Dec 1988

• Intersept* Crystalloid Cardioplegia Deliv. System

  Class II

  FDA 510(k) K885154 Active Cleared 22 Feb 1989

• Intersept* Crystalloid Cardioplegia Filter

  Class II

  FDA 510(k) K884390 Active Cleared 21 Dec 1988

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