Arrow Temporary Pacing Catheter Kit Recalled for Marketing Without FDA 510K Clearance
Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit (5 units) because it was marketed without FDA 510K clearance. Affected lot numbers: 16F20C0035 and 16F20F0124.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is classified as FDA Class II but lacks the reported hospitalizations or injuries required for higher severity ratings. The primary issue is regulatory—the product was marketed without required 510K clearance—with no reported product defect or patient harm.
Plain-English summary
Arrow International Inc is recalling the Arrow Temporary Pacing Catheter/Introducer Kit (Product Code AI-06210-IK) because it was marketed and distributed in the United States without required FDA 510K pre-market notification clearance.
The product is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording. Five units were distributed nationwide to medical facilities in Florida, Idaho, Illinois, New York, Ohio, and Texas. The affected lot numbers are 16F20C0035 and 16F20F0124.
Healthcare providers and facilities that may have received this product should review the accompanying instructions and contact their medical device supplier or Arrow International Inc for guidance on product status and potential return or replacement options.
The recalled product
- Product
- Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
- Manufacturer
- Arrow International Inc
- Hazard
- missing-510k
- regulatory-violation
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: 16F20C0035 16F20F0124
Distribution
Distributed nationwide across the United States.
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