Revolution Blood Pump with PC Coating, "revOlution… recallZ-0193-2010 · Sorin Group USA, Inc. · initiated Sep 25, 2009
Terminated All recalls posted in November 2009
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
A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.
FDA root cause category: Packaging change control
What the company is doing
Customers were notified by an Urgent: Field Safety Notice, dated 9/25/09, and instructed to: check their inventory for the affected product, complete the customer response form and return or visually inspect all affected product before use. For additional information contact Sorin Group Customer Service at 1-800-650-2623.
Recall details
- Recall number
- Z-0193-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 25, 2009
- Posted by the FDA
- Nov 13, 2009
- Recalling firm
- Sorin Group USA, Inc.
- Quantity
- 256 units
- Product code
- KFM
- FDA submissions
- K030462
- Distribution
- Worldwide Distribution -- US, Canada, Japan, and Europe.
Product description
Revolution Blood Pump with PC Coating, "revOlution Centrifugal pump Catalog# 050300700***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA, Inc. 14401 W. 65th way Arvada (CO) 80004-3599" Intended for use in cardiopulmonary bypass procedures.
Code information (models, lots, serial numbers)
Lot number: 0905220164.
Other devices under the same FDA submission
1 device cleared under K030462 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- REVOLUTION REVOLUTION PCSorin Group Italia Srl · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE2 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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