The Recall Desk
HighFDA (Devices)·Z-2105-2013·Announced 2013-09-04

Medtronic Perfusion Tubing Packs Recalled Due to Suction Wand Issue

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

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses, placing this in the High severity category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Inc. Cardiac Rhythm Disease Management is recalling Medtronic Custom Perfusion Systems with Carmeda BioActive Surface, specifically Model Numbers CB1D82R12 and CB5N73R7. These products are indicated for use in the extracorporeal circuit during cardiopulmonary surgery and are sterilized by Ethylene Oxide with a 'Do Not Reuse' designation.

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

The recall involves 217 units distributed worldwide, including nationwide in the United States (specifically California, Illinois, Louisiana, and Michigan) and in Canada. Affected lot numbers include 12096267, 12105099, 12139669, 12166396, 12198322, 12309957, 12416020, 206119223, 206120062, 206180336, 206233199, 206384131, 206496179, 206649807, 206699258, 206758209, 206851971, 206864385, 206919887, 207003072, and 207071455. Healthcare facilities should stop using the affected products and contact Medtronic for instructions on return or replacement.

The recalled product

Product
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
Category
Medical Device — Cardiac Surgery Equipment
Hazard
Affected units
217

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: 12096267
  • 12105099
  • 12139669
  • 12166396
  • 12198322
  • 12309957
  • 12416020
  • 206119223
  • 206120062
  • 206180336
  • 206233199
  • 206384131
  • 206496179
  • 206649807
  • 206699258
  • 206758209
  • 206851971
  • 206864385
  • 206919887
  • 207003072

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 →

Related recalls

Same manufacturer · Medtronic Inc. Cardiac Rhythm Disease Management

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Same hazard · component defect

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