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U.S. Department of Health and Human Services

Class 2 Device Recall DLP Pericardial/Intracardial Sump

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  Class 2 Device Recall DLP Pericardial/Intracardial Sump see related information
Date Initiated by Firm September 29, 2008
Date Posted January 26, 2009
Recall Status1 Terminated 3 on May 07, 2011
Recall Number Z-0609-2009
Recall Event ID 50173
510(K)Number K850385  
Product Classification Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing - Product Code DWF
Product DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.
Code Information Lot number 2006100305
Recalling Firm/
Manufacturer		 Medtronic Cardiovascular Revascularization & Surgical Therap
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact
763-391-9000
Manufacturer Reason
for Recall		 Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no adverse events affecting these patients.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were sent a "Medtronic Urgent Medical Device Recall Notice" dated October 1, 2008. The letter described the product and issue. It also requested its customers to return the product and to complete, sign and fax the Recall Certificate "Medtronic Recall Certificate (FCA 0902)". For further information, please contact Medtronic Cardiovascular Revascularization & Surgical Therap by telephone at 763-391-9000.
Quantity in Commerce 380 US ; 180 OUS
Distribution Worldwide Distribution --- including states of NC, PA, IA, WI, IN, VA, IL, KY, and TX, and countries of Australia, France, Hong Kong, Netherlands, and Poland.
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 = DLP, INC.
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