Arrow Pacing Catheter Kit Recalled for Missing FDA Premarket Clearance
Arrow International is recalling the Pacing Catheter Kit-Bipolar Electrode Catheter (48 units) due to marketing without required FDA premarket clearance (510K). Units were distributed nationwide in FL, ID, IL, NY, OH, and TX.
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 is an FDA Class II medical device recall without reported illnesses or injuries. The device was marketed without required premarket FDA clearance (510K), representing a risk-of-harm product where the hazard is regulatory non-compliance and lack of demonstrated safety review.
Plain-English summary
Arrow International Inc. is recalling the Arrow Pacing Catheter Kit-Bipolar Electrode Catheter, 5 Fr. 110 cm (Product Code: AI-05210). The device is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or electrocardiogram (ECG) recording. A total of 48 units were affected by this recall.
The device was marketed without required FDA premarket clearance (510K). Manufacturers of Class II medical devices must obtain 510K clearance from the FDA before marketing, demonstrating substantial equivalence to a legally marketed predicate device. This device did not receive such clearance prior to distribution.
Affected units were distributed to healthcare facilities in Florida, Idaho, Illinois, New York, Ohio, and Texas. Users should cease use of units bearing affected lot numbers (16F16F0057, 16F19D0027, 16F18B0040, 16F19E0157, 16F18E0121, 16F19F0093, 16F18F0058, 16F19G0066, 16F19C0082) and contact Arrow International Inc. for guidance on device handling and replacement.
The recalled product
- Product
- Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
- Manufacturer
- Arrow International Inc
- Affected units
- 48
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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