ROTAFLOW recallZ-2957-2020 · Maquet Cardiovascular Us Sales, Llc · initiated Aug 7, 2020
Terminated
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 Maquet Cardiovascular Us Sales, Llc 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
Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition
FDA root cause category: Labeling Change Control
What the company is doing
Maquet/Getinge issued Urgent Medical Device Correction letter dated August 7, 2020, issued via FedEx 2 day delivery. Letter states reason for recall, health risk and action take: Please examine your inventory immediately to determine if you have a Rotaflow System with a serial number of 94175452 or greater. The serial number tag is on the back of the device (see image below). Please contact your Getinge representative or email [email protected] to request 1 (one) revised IFU/(s). Please supply a mailing address, contact person and phone number on page 4. Please complete and return the form (page 4) to acknowledge this recall by emailing a scanned copy to [email protected] or by faxing the form to 18664771833. A revised IFU will be shipped to you as quickly as possible. In the mantime, please attach a copy of this letter to each copy of the affected IFU. Once you receive the revised IFU, please dispose of the old IFU with the incorrect serial number reference. Qquestions, telephone number +1 973 709 7412 or through email at [email protected].
Recall details
- Recall number
- Z-2957-2020
- Status
- Terminated
- Initiated by the company
- Aug 7, 2020
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 105 total: US: 11 each OUS: 94 each
- Product code
- KFM
- FDA submissions
- K991864
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of ME, NY, NV, OH, TX, VA, WA and the countries of China, Colombia, India, Italy, Mexico, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Arabic Emirates, United Kingdom.
Product description
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
Code information (models, lots, serial numbers)
Serial Numbers: 94175452 94175453 94175454 94175455 94175460 94175461 94175462 94175515 94175516 94175517 94175518 UDI: 04037691562445
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ROTAFLOW Console, English/ USMaquet Cardiopulmonary AG · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall5 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K991864 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ROTAFLOW DriveMaquet Cardiopulmonary AG · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall4 deaths9 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 16, 2026. Text above is shown as published by the FDA.
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