CLASS II ONGOING Device recall · Reported 21 Jul 2021 · FDA Enforcement Report
Arrow Temporary Pacing Catheter/Introducer Kit recalled
Arrow International is recalling Arrow Temporary Pacing Catheter/Introducer Kit, 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-2071-2021
- 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 Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - 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 Temporary Pacing Catheter/Introducer Kit recalled?
Yes. Arrow International recalled Arrow Temporary Pacing Catheter/Introducer Kit on 19 May 2021. The recall is Class II and its status is Ongoing. Recall number Z-2071-2021.
Why was it recalled?
Marketed without a 510K
Which lots are affected?
Lot Numbers: 23F20A0230 23F20E0004 23F20E0094
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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|---|---|---|---|---|---|
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| Device | CLASS I | Description/REF: Hemodialysis KIT: 2-Lumen 8 FR X 11 CM/AK-11802-F recalled | Arrow International | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Description/REF: PI CVC KIT recalled by Arrow International | Arrow International | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Description/REF: PI Picc: 3: 6FR x 55CM w CHG/ Dlx-35563-Hpkc; Agba recalled | Arrow International | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Description/REF: Pacing PSI KIT: 6 FR/AI-06210-KS, Pacing PSI KIT recalled | Arrow International | Lead & Heavy Metals | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |