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U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic Trillium Affinity

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 Class 3 Device Recall Medtronic Trillium Affinitysee related information
Date Initiated by FirmOctober 01, 2007
Date PostedJanuary 26, 2008
Recall Status1 Terminated 3 on October 23, 2008
Recall NumberZ-0476-2008
Recall Event ID 45485
510(K)NumberK936003 K973760 
Product Classification Cardiopulmonary Bypass Oxygenator - Product Code DTZ
ProductMedtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604.
Code Information Lot Numbers 8870107 and 8851934 (both Model 541T )
FEI Number 1000116158
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact
763-391-9000
Manufacturer Reason
for Recall		Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMedtronic sales force was notified and initiated calls with cutomers on 10/1/07. Additionally, certified Urgent Medical Device Recall letters dated 10/5/2007, were sent to the 32 customers. The letter explained the situaiton and requested that the impacted product be returned for replacement or credit. Medtronic is assessing patient use risks and will report those when determined. Standard post-surgical monitoring is advised at the present by Medtronic .
Quantity in Commerce34
DistributionNationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and AR.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTZ
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