The Recall Desk
HighFDA (Devices)·Z-2104-2013·Announced 2013-09-04

Medtronic Perfusion Tubing Packs Recalled Due to Defective Suction Wand

Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands recalled 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 involves a medical device used in cardiopulmonary surgery. While the specific hazard is not detailed in the source text, the use of a defective component in a life-support system represents a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Medtronic Inc. Cardiac Rhythm Disease Management is recalling specific lots of the Medtronic Custom Perfusion System. This recall is initiated because Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The affected Rigid Suction Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.

The affected products are the Medtronic Custom Perfusion System, specifically model numbers 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. These products are indicated for use in the extracorporeal circuit during cardiopulmonary surgery and are sterilized by Ethylene Oxide. The source text does not specify the exact nature of the defect in the Rigid Suction Wand or the specific hazards associated with its use.

A total of 13,223 units are affected by this recall. The products were distributed worldwide, including nationwide in the United States (specifically California, Illinois, Louisiana, and Michigan) and in Canada. Healthcare facilities and users should stop using the affected Perfusion Tubing Packs and contact Medtronic for further instructions regarding the recall.

The recalled product

Product
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmo
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
Category
Medical Device — Cardiac Surgery Equipment
Hazard
Affected units
13,223

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: 11110924
  • 11178379
  • 11281864
  • 11341336
  • 11346822
  • 11357000
  • 11386060
  • 11387461
  • 11412023
  • 11448066
  • 11501190
  • 11506220
  • 11506223
  • 11528161
  • 11552139
  • 11577959
  • 11600953
  • 11623004
  • 11664710
  • 11672387

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 · defective component

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