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
- Affected units
- 5
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
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.
See all 4 products in this recall →Related recalls
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · missing 510k
See all →- ModerateEdermy PIE Trolley System recalled for lacking FDA 510(k) clearance
FDA (Devices) · 2026-03-04
- ModerateEdermy PIE PAK units recalled for lacking FDA 510(k) clearance
FDA (Devices) · 2026-03-04
- HighMedical Probe Cover Recalled Due to Missing FDA Premarket Clearance
FDA (Devices) · 2021-06-30