FDA Medical Device Recalls (openFDA)
Medtronic Perfusion Systems: 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.
- Recall number
- Z-0583-2007
- 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.
- Status
- Terminated
- Initiated
- 2007-01-02
- Posted
- 2007-03-08
- Terminated
- 2008-02-24
- Reason
- 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.
- 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
- 17
- Distribution
- Illinois
- Lot, serial or model codes
- Lot 5666215
- 510(k) numbers
- ["K800178","K891687"]
- PMA numbers
- not on file
- Product code
- DWE
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28