Z-1075-06

6F ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 Coronary Guiding catheter designed to provide a pathway...

Name: Z-1075-06 6F ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 Coronary Guiding catheter designed to provide a pathway...
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 ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices... 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-1075-06
Status: Terminated
Initiated: 2006-04-05
Posted: 2006-06-01
Terminated: 2007-06-20
Recalling firm: Medtronic, Inc.
Product: 6F ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 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: ZM6SR40
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: 577 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: 0000000770 0000002134 0000028207 0000043814 0000090410 0000103759 0000125699 0000137834 0000151268 0000164481 127482 128283 128616 128988 130040 130595 132042 134208 135297 136396 138223 139414 141461 145170 152777 154356 155657 160606 166965 175986 186044 188373 204387 208088 217819 223496

Product code DQY

K981198Class IIMedtronic Zuma Guiding CatheterMedtronics Interventional Vascular / cleared 1998-08-07

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)