Arrow Bipolar Balloon Electrode Catheter Recalled for Marketing Without FDA 510K Clearance
Arrow International is recalling 4 units of an electrode catheter marketed without FDA 510(k) clearance. The device was intended for electrophysiology studies.
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: FDA Class II recall for a medical device marketed without required 510(k) clearance. This represents a risk-of-harm product where injury has not been reported. Regulatory non-compliance in device approval is significant even without reported incidents.
Plain-English summary
Arrow International Inc is recalling 4 units of the Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm (Product Code AI-07154, Lot Number 16F19J0109). The device is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
The device was marketed without obtaining required FDA 510(k) clearance. This regulatory violation indicates the device was distributed without FDA review and approval.
The recalled units were distributed nationwide across Florida, Idaho, Illinois, New York, Ohio, and Texas.
Facilities using this device should contact Arrow International Inc for further instructions. No illnesses or injuries related to this device have been reported.
The recalled product
- Product
- Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
- Manufacturer
- Arrow International Inc
- Affected units
- 4
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: 16F19J0109
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
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- 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
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
Similar recalls
- ModerateArrow Bipolar Electrode Catheter Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2018-09-26
- ModerateArrow FiberOptix Intra-Aortic Balloon Catheter Kit Recalled for Labeling Error
FDA (Devices) · 2015-03-11
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow Berman Angiographic Catheter Recalled for Potential Leak
FDA (Devices) · 2019-12-25
- ModerateArrow International Recalls PICC Kits Due to Incorrect Catheter Inclusion
FDA (Devices) · 2018-09-26