Z-1026-06

6F Z2 GUIDING CATHETER SR4.0 CATHETER Z26SR40 Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide...

Name: Z-1026-06 6F Z2 GUIDING CATHETER SR4.0 CATHETER Z26SR40 Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide...
Creator: Medtronic, Inc.
Published: 2006-04-05
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-04-05 / Terminated / root cause: packaging

FDA source

Medtronic, Inc. began a recall of 6F Z2 GUIDING CATHETER SR4.0 CATHETER Z26SR40 Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or... on 2006-04-05. The reason FDA records is "Potential for non-sterility due to loss of package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1026-06
Status: Terminated
Initiated: 2006-04-05
Posted: 2006-06-01
Terminated: 2007-06-20
Recalling firm: Medtronic, Inc.
Product: 6F Z2 GUIDING CATHETER SR4.0 CATHETER Z26SR40 Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR40
Product code: DQY Catheter, Percutaneous
Reason for recall: Potential for non-sterility due to loss of package integrity
Root cause tag: packaging
FDA root cause: Other
Action: Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Quantity in commerce: 645 units
Distribution: Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
Product codes and lots: Lot Numbers: 0000002433 0000006514 0000012046 0000027687 0000028673 0000033680 0000033718 0000043780 0000046956 0000067140 0000072965 0000076643 0000080168 0000081106 0000085973 0000095150 0000106493 0000134505 0000172339 178512 182950 186089 202512 205561 208500 211542 214599 215763 221279 222892

Product code DQY

K010579Class IIStent Support Guide CatheterMedtronic Vascular / cleared 2001-11-21

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)