Arrow Temporary Pacing Catheter Distributed Without FDA 510K Clearance
Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit because it was marketed without required FDA 510K clearance. Approximately 15 units were distributed in multiple U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device for cardiac procedures was distributed without FDA 510K premarket clearance, making it an unverified risk-of-harm product. Although no illnesses or injuries have been reported, the regulatory violation prevents verification of the device's safety and effectiveness.
Plain-English summary
Arrow International Inc is recalling the Arrow Temporary Pacing Catheter/Introducer Kit (Product Code AI-07155-IK) because it was marketed without FDA 510K clearance. The kit includes a 5 French pacing catheter and 6 French introducer for use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
The device was marketed without FDA 510K premarket notification, a required step in the FDA approval process for medical devices in this classification.
Approximately 15 units were distributed in the United States, including the states of Florida, Idaho, Illinois, New York, Ohio, and Texas. The affected lot numbers are 23F20A0230, 23F20E0004, and 23F20E0094.
Healthcare facilities and providers should immediately cease use of affected units and contact Arrow International Inc for instructions on return or replacement of the product.
The recalled product
- Product
- Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
- Manufacturer
- Arrow International Inc
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 23F20A0230 23F20E0004 23F20E0094
Distribution
Part of a larger recall action
This product is one of 4 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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