Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
Summary
The FDA issued a Class I for Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP- by ARROW INTERNATIONAL Inc.. Reason: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices..
Details
Source
Device Recall
External ID
Z-0441-2023
Action Date
2022-12-21
Status
Ongoing
Category
device
Product Description
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
Lot/Code Info: UDI/DI (01) 0 0801902 09125 3, (01) 0 0801902 09125 3, All Lot/Serial Numbers
Quantity Affected: N/A
Reason for Recall
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-17
Company
Morrisville, NC
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 474 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ARROW INTERNATIONAL Inc. has 55 FDA actions in our database, including 55 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ARROW INTERNATIONAL Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ARROW INTERNATIONAL Inc. have FDA actions?
ARROW INTERNATIONAL Inc. has 55 FDA actions in our database, including 55 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0441-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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