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Arrow International Inc Recall 88796

Description: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-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

Arrow International Inc Recall 88796 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0234-2022
Event ID88796
Event DescriptionArrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-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
Product TypeDevices
DistributionWorldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE CA CL CZ DE ES FR IL IT KR PH SA TR TW UK
Quantity1918 units
Recall Reason7FR 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.
Device Classification20211124
Device Code InfoLot Number: 13F19J0656 13F19K0368 13F19K0342 13F20C0596 13F20F0081 13F20F0229 13F20F0509 13F20F0578 13F20G0177 13F20G0566 13F20H0531 13F20J0379 13F20L0514 13F21A0354 13F21C0081 13F21C0749 13F21D0870 13F21E0415 13F21F1188
Center Classification Date20211118
Recall Initiation Date20210920
Recalling FirmArrow International Inc
Initial Notification Letter
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