—#65566

Product

Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604.

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K936003, K973760
Affected lot / code info: Lot Numbers 8870107 and 8851934 (both Model 541T )

Why it was recalled

Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Medtronic 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 .

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: Nationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and AR.

Timeline

Recall initiated: 2007-10-01
Posted by FDA: 2008-01-26
Terminated: 2008-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65566. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.