FDA Medical Device Recalls (openFDA)
Sorin Group USA, Inc.: SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set heart-lung bypass, Sterile EO, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
- Recall number
- Z-0769-2012
- Recalling firm
- Sorin Group USA, Inc.
- Product
- SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set heart-lung bypass, Sterile EO, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
- Status
- Terminated
- Initiated
- 2011-12-02
- Posted
- 2012-01-14
- Terminated
- 2012-06-13
- Reason
- Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
- Root cause
- Device Design
- Action
- Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
- Quantity
- 3,310 units (sold as standalone devices)
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- All Lots.
- 510(k) numbers
- ["K032040"]
- PMA numbers
- not on file
- Product code
- KFM
- 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