FDA Medical Device Recalls (openFDA)
Cardiac Assist, Inc: SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.
- Recall number
- Z-0311-2022
- Recalling firm
- Cardiac Assist, Inc
- Product
- SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.
- Status
- Open, Classified
- Initiated
- 2021-10-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)
- Root cause
- Error in labeling
- Action
- LiNova issued an "URGENT MEDICAL DEVICE REMOVAL" letter (FA-CP-PIT-2021-003) dated October 13th, 2021 via e-mail on 14 October 2021. Letter states reason for recall, health risk and action to take: TandemLife recommends using the device as labelled and dispose the outer packaging. TandemLife kindly requests your execution of the following actions: 1. Using attached Response Form in Attachment 1 of this letter, please: - If you have already discarded of outer packaging prior to the receipt of this letter, please proceed to step 2 - Check your inventory for the presence of potentially affected kit contained within your ordered kit as per Table provided in Attachment 1; - Please dispose of the outer packaging of your impacted product upon notification of this letter. - Please use your devices as labelled on the device level labeling. 2. Return the attached Response Form in Attachment 1 by email to LivaNova.FSCA@livanova.com to confirm appropriate corrective actions have been executed. Please return the Response Form even if each potentially affected device listed in Attachment 1 has already been used. For questions regarding this Medical Device Removal, please contact your TandemLife representative, or TandemLife Customer Quality at LivaNova.FSCA@livanova.com.
- Quantity
- 7 units
- Distribution
- US Distribution to states of: DC, MA, SC, and VA.
- Lot, serial or model codes
- Serial Numbers: 872170, 872171, 872172, 872173, 872182, 872183, 872184. UDI: 01)00814112020791(17)220 501(22)220511(21) 872170; (01)00814112020791(17)220 501(22)220511(21) 872171; (01)00814112020791(17)220 501(22)220511(21) 872172; (01)00814112020791(17)220 501(22)220511(21) 872173; (01)00814112020791(17)220 501(22)220511(21) 872182; (01)00814112020791(17)220 501(22)220511(21) 872183; 01)00814112020791(17)220 501(22)220511(21) 872184
- 510(k) numbers
- ["K160257"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 3002228812
- Firm city
- Pittsburgh
- Firm state
- PA
- 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