FDA Medical Device Recalls (openFDA)
Medtronic, Inc.: CATH. GUIDE 6F SR3.5 LAUNCHER CATHETER LA6SR35 LA 6F 100CM SR35 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 Number: LA6SR35
- Recall number
- Z-0958-06
- Recalling firm
- Medtronic, Inc.
- Product
- CATH. GUIDE 6F SR3.5 LAUNCHER CATHETER LA6SR35 LA 6F 100CM SR35 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 Number: LA6SR35
- 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
- 680 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: 0000001696 0000005659 0000009476 0000042018 0000044719 0000045231 0000064050 0000068017 0000068397 0000082398 0000084406 0000085999 0000095233 0000104293 0000104342 0000115247 0000123723 0000125309 0000138086 0000150459 0000169173 0000176133 176535 186865 201667 204626 205350 211785 213371 214942 220436
- 510(k) numbers
- ["K021256"]
- 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