Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous recall
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous…
Why was Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 13F19K0369 13F20A0323 13F20B0139 13F20C0594 13F20F0083 13F20F0230 13F20F0577 13F20H0756 13F20K0849 13F20L0283 13F20M0182 13F21A0498 13F21B0158 13F21C0747 13F21E0555
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous…
- Recalling firm
- Arrow International Inc
- Quantity
- 1245 units
- Distribution
- 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
- Recall date
- November 24, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)