FDA Medical Device Recalls (openFDA)
Sorin Group USA, Inc.: FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch
- Recall number
- Z-0076-2018
- Recalling firm
- Sorin Group USA, Inc.
- Product
- FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch
- Status
- Terminated
- Initiated
- 2017-09-28
- Posted
- not on file
- Terminated
- 2018-10-17
- Reason
- A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
- Root cause
- Process change control
- Action
- LivaNova sent an Urgent Medical Device Recall letter dated September 28 2017, to all affected consignees. The letter instructed customer to isolate products belonging to the lot involved. The level of the effectiveness check is Level A, where 100% of the consignees will be contacted. The customers were requested to send back any affected product and to complete the attached Customer Response Form by fax to 303-467-6502 or by email to USFSN@livanova.com. For questions customers were advised to contact Customer Service at 800-.650-2623.
- Quantity
- 40 units
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to France and Spain
- Lot, serial or model codes
- Lot: 181185; UDI: (01)10803622125812(240)200-200(17)200703(10)181185
- 510(k) numbers
- ["K052081"]
- PMA numbers
- not on file
- Product code
- DWF
- 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