Electrical Venous Occluder, Catalog 12-80-00, for use with… recallZ-2075-2010 · Sorin Group USA, Inc. · initiated Jun 18, 2010
Terminated All recalls posted in July 2010
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
Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5 system. The three accessories were not cleared for use with the HLM C5.
FDA root cause category: PMA
What the company is doing
The two customers who had received the suspect device accessories were identified and were contacted by letter on 6/18/2010. They were told to immediately discontinue use of the accessories and arrange for return of the products. They were also told that they could continue to use the CD5 Machine without the recalled accessories. A Product Recall Response Form was to completed by each consignee. Questions are directed to the firm at 800-221-7943.
Recall details
- Recall number
- Z-2075-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 18, 2010
- Posted by the FDA
- Jul 22, 2010
- Recalling firm
- Sorin Group USA, Inc.
- Quantity
- 1 unit
- Product code
- DWF
- FDA submissions
- K082344
- Distribution
- CA, PA, TN.
Product description
Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.
Code information (models, lots, serial numbers)
Serial number: 12K01077.
Other devices under the same FDA submission
2 devices cleared under K082344 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EVO OccluderLivaNova Deutschland GmbH · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS31 reports
- EVO Control UnitLivaNova Deutschland GmbH · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS5 reports
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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