Z-0340-2007

Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were...

Name: Z-0340-2007 Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were...
Creator: Medtronic Perfusion Systems
Published: 2006-09-13
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2006-09-13 / Terminated

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and... on 2006-09-13. The reason FDA records is "An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0340-2007
Status: Terminated
Initiated: 2006-09-13
Posted: 2007-01-25
Terminated: 2007-02-03
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user. The tubing is made of polyvinyl chloride (PVC). Portions of the tapered tubing are used in the vent, suction and arterial roller heads of the heart lung machine. Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604 USA. Tube supplier: Natvar (Tekni-Plex Co.), 19555 E. Arenth Ave., City of Industry, CA 91748.
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.
FDA root cause: Other
Action: An Important Customer Notification, dated 09/06/06, was sent to affected customers. The letter identifies the affected model and lot numbers. Medtronic requests that affected product be returned. A suplemental pack can be built and shipped to the customer upon request. Medtronic will replace all returned product. A Recall Certificate is asked to be completed by customer and faxed to Medtronic.
Quantity in commerce: 146
Distribution: Distributed in 6 states: CA, FL, IL, IN, LA and TN
Product codes and lots: The following Model / Lot Number are affected: CB4W39R1 / 4876667; 0A84R2 / 4531036; 1708R18 / 4627100; 0V68R4 / 4212182; 1P07R6 / 4433014; 1P07R6 / 4678134; 2Y91R / 4628170; 2Y91R / 4800224; 2Y91R / 4902036; CB0Q49R14 / 4800849; 4D87R2 / 4184927.

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