Extracorp.'s Intersept CUS Tubing PK

• • 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.

510(k) Number

K800178 ↗

FDA Product Code

DWE

Device Class

Class II

Regulation

21 CFR Part 870.4390

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Male Luer Connector & Hinged Cap

  Class II

  FDA 510(k) K820169 Active Cleared 5 Feb 1982

• Parallel Plate Dialyzer Holder

  Class II

  FDA 510(k) K811292 Active Cleared 2 Jun 1981

• Tracheostomy Tubes, Short and Long Term

  Class II

  FDA 510(k) K791044 Active Cleared 13 Jun 1979

• Ultrafiltration Controller

  Class II

  FDA 510(k) K832547 Active Cleared 3 Jan 1984

• Extracorporeals' Alternate Membrane

  Class II

  FDA 510(k) K801344 Active Cleared 21 Jul 1980

• Intersept* Venous Reservoir Bag & Holder

  Class II

  FDA 510(k) K803059 Active Cleared 22 Dec 1980

See all devices from Extracorporeal Medical Specialities, Inc. →

• What is the primary use of the Extracorporeal Medical Specialities, Inc. Intersept CUS Tubing PK in surgical settings?

  The Intersept CUS Tubing PK is designed specifically for cardiopulmonary bypass systems, ensuring the controlled flow of blood or fluids during surgeries requiring extracorporeal circulation. This makes it essential for procedures where cardiovascular support is critical, such as open-heart surgeries.

• Is the Intersept CUS Tubing PK intended for reuse, or is it meant for single-use only?

  The Intersept CUS Tubing PK is supplied as a sterile, single-use package, adhering to strict clinical standards for sterility and biocompatibility. It is not intended for reuse, as single-use devices minimize infection risks in controlled surgical environments.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety and equivalence?

  The device received FDA clearance through a Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets established safety and effectiveness standards for cardiopulmonary bypass tubing.

• Are there multiple sizes or models of the Intersept CUS Tubing PK, and how can I identify the correct one for my procedure?

  The device data lists multiple FEI numbers (e.g., 1000523114, 1721676, etc.), which correspond to different product codes (e.g., DWE) and regulatory filings. These likely represent variations in size, length, or internal diameter. Always verify the specific FEI number or product code required for your cardiopulmonary bypass system to ensure compatibility.

• How should the Intersept CUS Tubing PK be stored to maintain its sterility and performance?

  Since the device is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by keeping it sealed until immediate preoperative use, as per standard sterile medical device handling protocols.