Z-2104-2013Class II

Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4...

Name: Z-2104-2013 Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4...
Creator: Medtronic Inc. Cardiac Rhythm Disease Management
Published: 2013-07-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-07-17 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. Cardiac Rhythm Disease Management began a recall of Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do... on 2013-07-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2104-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-17
Posted: 2013-08-27
Terminated: 2014-02-04
Recalling firm: Medtronic, Inc.
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 cardiopulmonary surgery.
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Metronic sent an "Urgent Field Safety Notice" letter dated July, 2013 to all affected customers. The letter described the affected product, problem and actions to be taken by User. Customerss were advised to remove and destroy all affected products. At the same time customers were informed that replacement products can be ordered by contacting their Medtronic representative. Customers were requested to complete the Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612. For any questions they can contact Medtronic Lifeline Technical Services at 877-526-7890 or their Medtronic representative.
Quantity in commerce: 13223
Distribution: Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2104-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2104-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2105-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2106-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27

Product code DWE

K800178Class IIExtracorp.'s Intersept Cus. Tubing Pk.Extracorporeal Medical Specialities, Inc. / cleared 1980-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)