Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE recall
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
Why was Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE recalled?
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.
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?
Serial Number Ranges: AUTOCAT2 WAVE ITALIAN IAP-0500I 160516W 160619W 160804W 160828W 170209W through 170210W 170302W 180309W
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
- Recalling firm
- Arrow International Inc
- Quantity
- 2123 total
- Distribution
- Worldwide distribution.
- Recall date
- July 8, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)