Medtronic Trillium Affinity NT, 541T, Integrated… recallZ-0476-2008 · Medtronic Perfusion Systems · initiated Oct 1, 2007
Terminated All recalls posted in January 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 .
Recall details
- Recall number
- Z-0476-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 1, 2007
- Posted by the FDA
- Jan 26, 2008
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 34
- Product code
- DTZ
- FDA submissions
- K936003, K973760
- Distribution
- Nationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and AR.
Product description
Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604.
Code information (models, lots, serial numbers)
Lot Numbers 8870107 and 8851934 (both Model 541T )
Other devices under the same FDA submission
1 device cleared under K936003, K973760 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TRILLIUM® AFFINITY NT® 95217Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 45485).
- Z-0477-2008 · TerminatedMedtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Minneapolis, MN 55432-5804
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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