Z-1001-06

CATHETER SB63DRC SB 6F 100CM 3 CATHETER SB63DRC SB 6F 100CM 3DRC Coronary Guiding catheter designed to...

Name: Z-1001-06 CATHETER SB63DRC SB 6F 100CM 3 CATHETER SB63DRC SB 6F 100CM 3DRC Coronary Guiding catheter designed to...
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 CATHETER SB63DRC SB 6F 100CM 3 CATHETER SB63DRC SB 6F 100CM 3DRC 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-1001-06
Status: Terminated
Initiated: 2006-04-05
Posted: 2006-06-01
Terminated: 2007-06-20
Recalling firm: Medtronic, Inc.
Product: CATHETER SB63DRC SB 6F 100CM 3 CATHETER SB63DRC SB 6F 100CM 3DRC 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: SB63DRC
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: 341units
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: 0000055758 0000055759 0000055760 0000070849 0000071307 0000071309 0000073024 0000073025 0000075756 0000080599 0000082939 0000093035 0000096718 0000097929 0000100993 0000103729 0000110816 0000113625 0000114979 0000126421 0000130789 0000134456 0000141335 0000148442 0000149211 0000154614 0000173136 0000173875 0000175333

Product code DQY

K021256Class IIZ3 Guide CatheterMedtronic Vascular / cleared 2002-05-17

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)