FDA Medical Device Recalls (openFDA)
Medtronic Neurosurgery: Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F
- Recall number
- Z-1110-05
- Recalling firm
- Medtronic Neurosurgery
- Product
- Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F
- Status
- Terminated
- Initiated
- 2005-07-05
- Posted
- 2005-08-10
- Terminated
- 2008-06-26
- Reason
- Cracked hubs/handles and/or improper peeling of the sheath during use.
- Root cause
- Other
- Action
- Firm sent recall letters by Fedex on July 5, 2005 to all customers.
- Quantity
- 366
- Distribution
- Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, United Kingdom.
- Lot, serial or model codes
- Lots: A46413, A6414, A48711, A49692, A53066, A53867, A55500, A55753, A57046, A58460, A60519, A61343, A67224.
- 510(k) numbers
- ["K990333"]
- PMA numbers
- not on file
- Product code
- GWG
- Firm FEI
- 3015531529
- Firm city
- Goleta
- Firm state
- CA
- 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