The Recall Desk
HighFDA (Devices)·Z-2068-2021·Announced 2021-07-21

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.

What this means for you

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
Category
Medical Device — Cardiac Electrophysiology
Hazard
  • regulatory-non-compliance
  • unapproved-device

Distribution

Distributed nationwide across the United States.

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