CS 100 Intra-Aortic Balloon Pump recall
CS 100 Intra-Aortic Balloon Pump
Why was CS 100 Intra-Aortic Balloon Pump recalled?
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
0998-XX-3013-XX, 0998-UC-3013-XX
- Product
- CS 100 Intra-Aortic Balloon Pump
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Quantity
- 12,319 units total
- Distribution
- Worldwide Distribution - (in over 100 countries) US (Nationwide)
- Recall date
- August 2, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)