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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Select CAP Arterial Cannula

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  Class 2 Device Recall Medtronic Select CAP Arterial Cannula see related information
Date Initiated by Firm January 30, 2014
Date Posted February 20, 2014
Recall Status1 Terminated 3 on October 06, 2014
Recall Number Z-0998-2014
Recall Event ID 67400
510(K)Number K010737  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic.

The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body. The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation. The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap. The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. The proximal end features a pressure monitoring line with a 3-way stopcock.

These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Code Information Model 78818, Lot Numbers: 2011021826, 2011070534, 2011090245, 2011110207,  2011111844.   Model 78820, Lot Numbers: 2011062305, 2011072337.   Model 78822, Lot Number: 2011011178  Model 78920, Lot Numbers: 2011050717, 2011082464, 2011120308, 2012070891,  2012071268, 2013081135, 2013121551, 201106C038.   Model 78922, Lot Numbers: 2011011187, 2011020121, 2011020785, 2011021532,  2011070801, 2011081266, 2011090483, 2012012160, 2012021436, 2012021695,  2012071735, 2013010416, 2013030273, 2013050807, 2013051036, 2013070174,  2013091410, 2013101028, 201311C767.   Model 78924, Lot Numbers: 2011041201, 2011041542, 2011080058, 2011080606,  2011081545, 2011081637, 2011110914, 2012031176, 2012051794, 2012100256,  2012111224, 2013030583, 2013050865, 2013060210. 
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul MN 55112-4391
For Additional Information Contact Customer Service
800-854-3570
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Medtronic, sent an "Urgent Medical Device Recall" letter dated January, 2014 via UPS on January 30, 2014 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify and quarantine all listed product in your inventory; return all listed product to Medtronic and contact Customer Service at 800 854-3570 and reference RADAR #167826 to initiate a return and credit of product; complete and return the attached Customer Confirmation Certificate via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality, and share this notification with others in your organization as appropriate. Select 3D and Select CAP Arterial Cannula are not available for purchase at this time. Please contact your Medtronic sales representative or Medtronic LifeLine Technical Services at 1 877-526-7890 or (+1 763) 526-7890 to assist with alternative cannula selection and any additional questions you may have related to this notification.
Quantity in Commerce 19483 total (7669 US, 11814 OUS)
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC CARDIAC SURGICAL PRODUCTS
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