CLASS II Device recall · Reported 4 Sep 2013 · FDA Enforcement Report

Medtronic Custom Perfusion System with Trillium BioSurface recalled

Medtronic Inc. Cardiac Rhythm Disease Management is recalling Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing, distributed nationwide in the US. The recall was initiated on 17 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 11646955, 11669565, 11672312, 11713195, 11724203, 11749965, 11750036, 11787651, 11799982, 11822299, 11822308, 11878727, 11892549, 11908754, 11977672, 11982378, 11990416, 12019895, 12033691, 12075354, 12089790, 12096228, 12105079, 12111165, 12139696, 12155284, 12172596, 12178118, 12182890, 12191658, 12204951, 12204958, 12221793, 12227544, 12233759, 12236465, 12292171, 12323842, 12385431, 12399363, 12403798, 206110970, 206141990, 206142625, 206388507, 206476850, 206618547, 206649829, 206720637, 206758173, 206758215, 206851679, 206919848, 207003064, and 207030516.

Quantity recalled758

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2106-2013
FDA event ID: 65831
Recalling firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 17 Jul 2013
FDA classified: 27 Aug 2013
Reported: 4 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

17 Jul 2013	Recall initiated by company
27 Aug 2013	Classified by FDA	+41 days
4 Sep 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.

Where it was distributed

Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA

Nationwide California Illinois Louisiana Michigan

Questions about this recall

Is Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing recalled?

Yes. Medtronic Inc. Cardiac Rhythm Disease Management recalled Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing on 17 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-2106-2013.

Why was it recalled?

Which lots are affected?

Lot: 11646955, 11669565, 11672312, 11713195, 11724203, 11749965, 11750036, 11787651, 11799982, 11822299, 11822308, 11878727, 11892549, 11908754, 11977672, 11982378, 11990416, 12019895, 12033691, 12075354, 12089790, 12096228, 12105079, 12111165, 12139696, 12155284, 12172596, 12178118, 12182890, 12191658, 12204951, 12204958, 12221793, 12227544, 12233759, 12236465, 12292171, 12323842, 12385431, 12399363, 12403798, 206110970, 206141990, 206142625, 206388507, 206476850, 206618547, 206649829, 206720637, 206758173, 206758215, 206851679, 206919848, 207003064, and 207030516.

Where was it sold?

Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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