CLASS I Device recall · Reported 24 Nov 2021 · FDA Enforcement Report
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic recalled
Arrow International is recalling Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic, distributed nationwide in the US. The recall was initiated on 20 Sep 2021 and the FDA has classified it as Class I.
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-0231-2022
- FDA event ID
- 88796
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Sep 2021
- FDA classified
- 18 Nov 2021
- Reported
- 24 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 20 Sep 2021 | Recall initiated by company | |
| 18 Nov 2021 | Classified by FDA | +59 days |
| 24 Nov 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
Product as listed by the FDA
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
Where it was distributed
Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE CA CL CZ DE ES FR IL IT KR PH SA TR TW UK
Questions about this recall
Is Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic recalled?
Yes. Arrow International recalled Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic on 20 Sep 2021. The recall is Class I and its status is Terminated. Recall number Z-0231-2022.
Why was it recalled?
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
Which lots are affected?
Lot Number: 13F19K0564 13F20C0094 13F20G0284 13F20L0282 13F21A0497 13F21A0718 13X21E0008 13F21F1187
Where was it sold?
Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE CA CL CZ DE ES FR IL IT KR PH SA TR TW UK
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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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| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |