Medtronic Custom Perfusion System with Carmeda BioActive… recallZ-2105-2013 · Medtronic Inc. Cardiac Rhythm Disease Management · initiated Jul 17, 2013
Class II Terminated All recalls posted in August 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc. Cardiac Rhythm Disease Management or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2105-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 17, 2013
- Posted by the FDA
- Aug 27, 2013
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Quantity
- 217
- Product code
- DTZ
- FDA submissions
- K891687
- Distribution
- Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
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.
Code information (models, lots, serial numbers)
Lot: 12096267, 12105099, 12139669, 12166396, 12198322, 12309957, 12416020, 206119223, 206120062, 206180336, 206233199, 206384131, 206496179, 206649807, 206699258, 206758209, 206851971, 206864385, 206919887, 207003072, and 207071455.
Other devices under the same FDA submission
42 devices cleared under K891687 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA CB7X82R4Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7J98R7Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7J97R8Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB10W63R1Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall2 reports
- NA CB4Z27RMedtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB5S68R3Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB6M85R7Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB7D52RMedtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB6Z18R3Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB7J45R2Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB7N52RMedtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB7N54R1Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 65831).
- Z-2104-2013 · TerminatedMedtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Pr…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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