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Recall Observatory FDA recall evidence

Device 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.

Z-2105-2013

July 17, 2013

Class II

Product summary

Firm
Medtronic Inc. Cardiac Rhythm Disease Management
Event
Event 65831
Status
Terminated
Classification
Class II
Quantity
217
Official record key
device-enforcement:Z-2105-2013

Official wording

Reason: 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.

Code information: Lot: 12096267, 12105099, 12139669, 12166396, 12198322, 12309957, 12416020, 206119223, 206120062, 206180336, 206233199, 206384131, 206496179, 206649807, 206699258, 206758209, 206851971, 206864385, 206919887, 207003072, and 207071455.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.