Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-1000-2014

Z-1000-2014 Class II Terminated

Recalled by Medtronic Inc. Cardiac Rhythm Disease Management — Saint Paul, MN

FDA device recall Z-1000-2014 was initiated by Medtronic Inc. Cardiac Rhythm Disease Management on January 30, 2014 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated October 6, 2014). Affected quantity: 19483 total (7669 US, 11814 OUS).

Recall Details

Product Type: Devices
Report Date: February 26, 2014
Initiation Date: January 30, 2014
Termination Date: October 6, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 19483 total (7669 US, 11814 OUS)

Product Description

Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.

Reason for Recall

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.

Distribution Pattern

Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.

Code Information

Model 3Y90R3, Lot numbers: 12227513, 12277464, 206420618, 206618641, 206842458, 206932996, 207184816. Model C300901B, Lot number 206499164.

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