Product Safety Recalls

Product Recall Tracker

Arrow International Inc Recall 88796

Description: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W 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-0233-2022
Event ID88796
Event DescriptionArrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W 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
Quantity1167 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: 13F19M0129 13F20B0053 13F20C0595 13F20F0231 13F20G0361 13F20K0632 13F21A0353 13F21C0748 13F21D0721 13F21E0823 13F21F1189
Center Classification Date20211118
Recall Initiation Date20210920
Recalling FirmArrow International Inc
Initial Notification Letter
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.