Z-2616-2010

Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485

Name: Z-2616-2010 Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485
Creator: Terumo Cardiovascular Corporation
Published: 2010-06-08
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2010-06-08 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Corporation began a recall of Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485 on 2010-06-08. The reason FDA records is "Medical device vent port may be occluded and prevent delivery of priming fluid". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2616-2010
Status: Terminated
Initiated: 2010-06-08
Posted: 2010-09-29
Terminated: 2012-02-29
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485
Product code: DTR Heat-Exchanger, Cardiopulmonary Bypass
Reason for recall: Medical device vent port may be occluded and prevent delivery of priming fluid.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 2010.
Quantity in commerce: 32 kits
Distribution: The products were distributed nationwide.
Product codes and lots: Lot Number MD29

Product code DTR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)