Dual Stage Venous Return Catheter, Low-Profile, wire… recallZ-0813-2016 · Sorin Group USA, Inc. · initiated Jan 25, 2016
Class II Terminated All recalls posted in February 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sorin Group USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.
FDA root cause category: Employee error
What the company is doing
LivaNova sent an Urgent Safety Alert dated January 25, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advice on action to be taken: "Remove and discard the IFU included within the case packaging for the product. "A copy of the correct IFU (Part Number 435085202, Revision B) is attached with this letter "Print copies of the IFU and place with the product. For questions regarding this notice, please contact Customer Service at 1-800-650-2623 (Monday to Friday BAM to 5PM MT) or e-mail [email protected]. We sincerely apologize for this inconvenience and thank you in advance for your support
Recall details
- Recall number
- Z-0813-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 25, 2016
- Posted by the FDA
- Feb 16, 2016
- Recalling firm
- Sorin Group USA, Inc.
- Quantity
- 60
- Product code
- DWF
- FDA submissions
- K943934
- Distribution
- US Distribution to CA., and Internationally to Canada.
Product description
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.
Code information (models, lots, serial numbers)
lot - 1529300018
Other devices under the same FDA submission
7 devices cleared under K943934 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Arterial cardiopulmonary bypass cannula RA-xxxxxLivanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS3 reports
- Arterial cardiopulmonary bypass cannula RA-xxxxxLivanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 reports
- Venous cardiopulmonary bypass cannula LR-xxxxxLivanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Venous cardiopulmonary bypass cannula LR-xxxxxLivanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Arterial cardiopulmonary bypass cannula NA-xxxxxLivanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Arterial cardiopulmonary bypass cannula RA-xxxxxLivanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Venous cardiopulmonary bypass cannula RT-xxxxxLivanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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