Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE recall
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
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 SPANISH IAP-0500E 150302W 150304W 150402W through 150403W 150408W 150514W 150826W 151014W 151107W 151110W 160425W through 160427W 160508W through 160510W 160518W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH IAP-0500E 160631W 160637W 160642W 160644W 160705W 160919W 170204W through 170206W 170221W 170308W 170328W 170928W 171116W 180333W 180840W 180939W 181054W 181056W through 181060W 190229W 190512W 190514W 190519W 190631W through 190633W
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
- Recalling firm
- Arrow International Inc
- Quantity
- 2123 total
- Distribution
- Worldwide distribution.
- Recall date
- July 8, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)