CLASS II ONGOING Device recall · Reported 21 Jul 2021 · FDA Enforcement Report
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter., Product recalled
Arrow International is recalling Arrow Pacing Catheter Kit-Bipolar Electrode Catheter., Product, distributed nationwide in the US. The recall was initiated on 19 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2068-2021
- FDA event ID
- 88120
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 May 2021
- FDA classified
- 13 Jul 2021
- Reported
- 21 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 19 May 2021 | Recall initiated by company | |
| 13 Jul 2021 | Classified by FDA | +55 days |
| 21 Jul 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without a 510K
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Questions about this recall
Is Arrow Pacing Catheter Kit-Bipolar Electrode Catheter., Product recalled?
Yes. Arrow International recalled Arrow Pacing Catheter Kit-Bipolar Electrode Catheter., Product on 19 May 2021. The recall is Class II and its status is Ongoing. Recall number Z-2068-2021.
Why was it recalled?
Marketed without a 510K
Which lots are affected?
Lot Numbers: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082
Where was it sold?
US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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