FDA Medical Device Recalls (openFDA)
LivaNova USA Inc.: LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
- Recall number
- Z-1119-2020
- Recalling firm
- LivaNova USA Inc.
- Product
- LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
- Status
- Terminated
- Initiated
- 2019-01-28
- Posted
- not on file
- Terminated
- 2022-01-31
- Reason
- Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.
- Root cause
- Error in labeling
- Action
- On 01/28/2019, a Medical Device Correction letter was mailed to affected consignees. The letter asked customers to take the following actions: 1. Please check your inventory using the list of affected products delivered to your facility in Attachment 1; 2. Using the attached Customer Response Form (Attachment 2), please respond by email to USFSN@livanova.com to confirm that you have affected products in your facility. Your LivaNova reference person will contact you for the replacement of the product labels with labels bearing the correct manufacturing date. 3. Please ensure that this Medical Device Correction is communicated to all personnel within your organization who need to be aware of it. If you have transferred any of the affected devices to a third party, please communicate this information to them and inform the LivaNova Quality Assurance Team at USFSN@livanova.com. 4. For questions regarding this Medical Device Correction, please contact us at (800) 986-4702 or by e-mail to USFSN@livanova.com.
- Quantity
- 5 Datapads
- Distribution
- US: NJ and CA
- Lot, serial or model codes
- Device Model, Catalog Number, Serial Number: SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0247 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0249 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0250 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0258 DATAPADIII WITHOUT SOFTWARE, 24-90-87, 17BQC0257
- 510(k) numbers
- ["K071318"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 1718850
- Firm city
- Arvada
- Firm state
- CO
- 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