FDA Device recall Z-0309-2017
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera…
- FDA Device
- Class I
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class I recall of Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera… by Micro Therapeutics, citing delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0309-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-10-05 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Micro Therapeutics |
| Distribution | US |
Product
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
Reason
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Identifiers
| code_info | 9946730 9960999 9965968 9974493 A004327 A011297 A016502 A024591 9952156 9961016 9965970 9975117 A004329 A0…9946730 9960999 9965968 9974493 A004327 A011297 A016502 A024591 9952156 9961016 9965970 9975117 A004329 A011515 A016504 A024594 9952519 9961297 9965980 9975118 A004435 A011522 A016507 A024893 9952892 9961308 9965983 9976018 A004436 A011731 A016510 A024894 9953171 9961313 9965984 9976024 A004437 A011735 A016632 A024896 9953177 9963245 9966022 9976049 A004535 A011818 A017149 A025130 9953699 9963247 9966200 9976052 A004537 A011845 A017150 A025857 9953892 9963249 9966203 9976055 A004542 A011972 A017154 A025862 9955091 9963378 9966205 9978598 A004543 A012088 A018239 A026331 9955406 9963380 9966550 A000215 A004544 A012341 A018301 A026336 9955408 9963382 9966562 A000219 A004614 A012591 A018307 A026337 9955530 9963386 9966563 A000220 A004616 A012691 A018310 A026375 9955561 9963622 9966674 A000369 A005866 A012738 A018721 A027449 9955726 9963627 9966674 A000453 A005870 A012743 A018722 A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0309-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.