Medtronic Inc. Cardiac Rhythm Disease Management: Medical Device Recall in 2013 - (Recall #: Z-2104-2013)

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. 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 cardiopulmonary surgery.

Product Classification:

Class II

Date Initiated: July 17, 2013

Date Posted: September 4, 2013

Recall Number: Z-2104-2013

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: 13223

Code Information:

Lot: 11110924, 11178379, 11281864, 11341336, 11346822, 11357000, 11386060, 11387461, 11412023, 11448066, 11501190, 11506220, 11506223, 11528161, 11552139, 11577959, 11600953, 11623004, 11664710, 11672387, 11718344, 11719034, 11736936, 11816427, 11839402, 11843611, 11869817, 11896503, 11930457, 11995799, 11995883, 12000022, 12024743, 12024776, 12075385, 12093515, 12096289, 12166420, 12249817, 12264661, 12309956, 12374421, 12411720, 206168235, 206219230, 206325047, 206388493, 206476804, 206581948, 206597875, 206689812, 206709358, 206720707, 206851972, 206852054, 206864691, 206904419, 206991490, 207003054, 207100337, and 207121513.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated