Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
Reported: July 8, 2020 Initiated: May 20, 2020 #Z-2416-2020
Product Description
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
Reason for Recall
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.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 2123 total
- Distribution
- Worldwide distribution.
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700. Recalled by Arrow International Inc. Units affected: 2123 total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2020. Severity: Critical. Recall number: Z-2416-2020.
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