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FDA Medical Device Recalls (openFDA)

Medtronic, Inc.: CATH. GUIDE 7F 3DRCC LAUNCHER CATHETER LA73DRC LA 7F 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: LA73DRC

Recall number
Z-0969-06
Recalling firm
Medtronic, Inc.
Product
CATH. GUIDE 7F 3DRCC LAUNCHER CATHETER LA73DRC LA 7F 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: LA73DRC
Status
Terminated
Initiated
2006-04-05
Posted
2006-06-01
Terminated
2007-06-20
Reason
Potential for non-sterility due to loss of package integrity
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
416 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.
Lot, serial or model codes
Lot Numbers: 0000006813 0000009012 0000009040 0000015848 0000031930 0000043653 0000043655 0000055236 0000055686 0000060347 0000068443 0000068446 0000074855 0000074857 0000079601 0000081441 0000083822 0000091563 0000097895 0000101072 0000101074 0000105403 0000115013 0000117385 0000123711 0000133675 0000138054 0000144973 0000149842 0000153958 0000160711 0000170645 0000174447 0000175189 0000187845 181734 184271 185910 187134 188547 201685 203306 205597 207631 208906 211159 214999 216576 218842 219217 221352
510(k) numbers
["K022764"]
PMA numbers
not on file
Product code
DQY
Firm FEI
1220452
Firm city
Danvers
Firm state
MA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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