FDA Medical Device Recalls (openFDA)
Medtronic Cardiovascular Revascularization & Surgical Therap: Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
- Recall number
- Z-1424-2009
- Recalling firm
- Medtronic Cardiovascular Revascularization & Surgical Therap
- Product
- Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
- Status
- Terminated
- Initiated
- 2009-02-25
- Posted
- 2009-06-23
- Terminated
- 2011-05-07
- Reason
- Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. Use of the product may cause serious health consequences from potential sepsis/infection and the associated remote risk of death.
- Root cause
- Device Design
- Action
- Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" letter dated March 5, 2009. The letter was addressed to Risk Manager. The letter described the product and problem and requested the consignee to complete, sign and return the certificate acknowledgement.
- Quantity
- 20 units
- Distribution
- Distribution to one medical facility in MN.
- Lot, serial or model codes
- Lot 10279571, Use By 2012-01-31
- 510(k) numbers
- ["K800178"]
- PMA numbers
- not on file
- Product code
- DWE
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- Firm state
- MN
- 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