The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2106-2013·Announced 2013-09-04

Medtronic Perfusion Tubing Packs Recalled Due to Component Issue

Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary precautionary action triggered by a component recall from another manufacturer, with no specific injuries or illnesses reported in the source text.

Plain-English summary

Medtronic Inc. Cardiac Rhythm Disease Management is recalling certain Perfusion Tubing Packs. These packs are manufactured and distributed by Medtronic and are indicated for use in the extracorporeal circuit during cardiopulmonary surgery. The recall is being initiated because the packs include Rigid Suction Wands, model S099B, which are subject to a product recall initiated by Edwards Lifesciences.

The affected products are Medtronic Custom Perfusion Systems with Trillium BioSurface, including model numbers TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. A total of 758 units are involved in this recall. The products were distributed worldwide, including nationwide in the United States and in Canada.

Healthcare providers and facilities should stop using the affected Perfusion Tubing Packs and contact Medtronic for instructions on how to return or dispose of the products. This recall is a precautionary measure to address the issue with the included Rigid Suction Wands.

The recalled product

Product
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…
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
Category
Medical Device — Cardiac Surgery Equipment
Hazard
Affected units
758

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot: 11646955
  • 11669565
  • 11672312
  • 11713195
  • 11724203
  • 11749965
  • 11750036
  • 11787651
  • 11799982
  • 11822299
  • 11822308
  • 11878727
  • 11892549
  • 11908754
  • 11977672
  • 11982378
  • 11990416
  • 12019895
  • 12033691
  • 12075354

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Medtronic Inc. Cardiac Rhythm Disease Management under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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