FDA Medical Device Recalls (openFDA)
Medtronic Cardiovascular Revascularization & Surgical Therap: Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below: Medtronic Bio-Console 550 centrifugal pump console, Model #95180, Catalogue # 95180, E95180, R95180. Medtronic Bio-Console 560 centrifugal pump consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1. Medtronic autoLog, Model # ATLG110, Catalogue # ATLG110, ATLG110E ATLG110R. Medtronic Sequestra 1000, Model #SEQ1000, Catalogue # SEQ1000, SEQ1000E, SEQ1000R.
- Recall number
- Z-1939-2010
- Recalling firm
- Medtronic Cardiovascular Revascularization & Surgical Therap
- Product
- Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below: Medtronic Bio-Console 550 centrifugal pump console, Model #95180, Catalogue # 95180, E95180, R95180. Medtronic Bio-Console 560 centrifugal pump consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1. Medtronic autoLog, Model # ATLG110, Catalogue # ATLG110, ATLG110E ATLG110R. Medtronic Sequestra 1000, Model #SEQ1000, Catalogue # SEQ1000, SEQ1000E, SEQ1000R.
- Status
- Terminated
- Initiated
- 2010-04-21
- Posted
- 2010-06-30
- Terminated
- 2011-12-24
- Reason
- The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no reports of adverse events related to the affected cord, a failure may potentially lead to serious adverse health consequences, depending on the device, and therapy being interrupted. This Field Notificatio
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were sent on 4/21/10 a Medtronic "Urgent Medical Device Recall Notice" letter dated April 19, 2010. The letter was addressed to their customers and described the problem and the product involved. They recommended to discontinue use of the AC power cords and to destroy them. Requested consignees to fill out the attached Medtronic Recall Certificate (FCA 1005), and return it to Medtronics.
- Quantity
- 619 USA, 80 OUS
- Distribution
- Worldwide distribution: USA, Latin America, Middle East, Japan, and Canada.
- Lot, serial or model codes
- Part # 66319 & 055476
- 510(k) numbers
- ["K051303","K941921","K972894"]
- PMA numbers
- not on file
- Product code
- DWA
- 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