Z-0583-2007

Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch...

Name: Z-0583-2007 Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch...
Creator: Medtronic Perfusion Systems
Published: 2007-01-02
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2007-01-02 / Terminated

FDA source

Medtronic Perfusion Systems began a recall of 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... on 2007-01-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0583-2007
Status: Terminated
Initiated: 2007-01-02
Posted: 2007-03-08
Terminated: 2008-02-24
Recalling firm: Medtronic Perfusion Systems
Product: 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.
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: 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: Other
Action: 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.
Quantity in commerce: 17
Distribution: Illinois
Product codes and lots: Lot 5666215

Product code DWE

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)