Medtronic Inc. Cardiac Rhythm Disease Management: Medical Device Recall in 2013 - (Recall #: Z-2105-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 17, 2013

Date Posted: September 4, 2013

Recall Number: Z-2105-2013

Event ID: 65831

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.

Status: Terminated

Product Quantity: 217

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

Voluntary or Mandated:

Voluntary: Firm initiated