Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack… recallZ-0583-2007 · Medtronic Perfusion Systems · initiated Jan 2, 2007
Terminated All recalls posted in March 2007
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 Perfusion Systems 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
One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.
FDA root cause category: Other
What the company is doing
There was only one customer. The customer was sent a letter on December 29, 2006, requesting that the impacted product be disposed of or returned to Medtronic for disposal.
Recall details
- Recall number
- Z-0583-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 2, 2007
- Posted by the FDA
- Mar 8, 2007
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 17
- Product code
- DWE
- FDA submissions
- K800178, K891687
- Distribution
- Illinois
Product description
Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass.
Code information (models, lots, serial numbers)
Lot 5666215
Other devices under the same FDA submission
155 devices cleared under K800178, 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 BB9L72R1Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS3 recalls0 reports
- NA BB8M16R3Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls1 report
- NA BB7P48R4Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA BB7P46R4Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7X82R4Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA BB8L58R3Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA BB8B70R7Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7J98R7Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7J97R8Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA BB8D40R3Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA BB8T77R2Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB10W63R1Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall2 reports
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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