Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trer
Summary
The FDA issued a Class I for Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Pro by Arrow International Inc. Reason: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additiona.
Details
Source
Device Recall
External ID
Z-0232-2022
Action Date
2021-11-24
Status
Terminated
Category
device
Product Description
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC 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
Lot/Code Info: Lot Number: 13F19K0369 13F20A0323 13F20B0139 13F20C0594 13F20F0083 13F20F0230 13F20F0577 13F20H0756 13F20K0849 13F20L0283 13F20M0182 13F21A0498 13F21B0158 13F21C0747 13F21E0555
Quantity Affected: 1245 units
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-20
Company
Reading, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Arrow International Inc has 55 FDA actions in our database, including 55 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Arrow International Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Arrow International Inc have FDA actions?
Arrow International Inc has 55 FDA actions in our database, including 55 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0232-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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