Z-1110-2007

Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer...

Name: Z-1110-2007 Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer...
Creator: Medtronic Perfusion Systems
Published: 2007-04-18
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2007-04-18 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN on 2007-04-18. The reason FDA records is "Pyrogen Levels detected above specification: The product contains a pyrogen level above Medtronic''s internal specifications while the product is labeled as nonpyrogenic". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1110-2007
Status: Terminated
Initiated: 2007-04-18
Posted: 2007-07-26
Terminated: 2007-11-01
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Pyrogen Levels detected above specification: The product contains a pyrogen level above Medtronic''s internal specifications while the product is labeled as nonpyrogenic.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The consignees were notified by personal contact and requested to stop using the devices in question. A customer letter (April 24, 2007) will be sent by e-mail which explains the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a Recall Certificate acknowledging the receipt of this information.
Quantity in commerce: 11 units
Distribution: Nationwide: Distributed to states of CO and PA
Product codes and lots: Lot 7192800

Product code DTZ

K926226Class IIIntersept Filtered Cardiotomy ReservoirMedtronic Vascular / cleared 1993-06-22

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)