FDA Device recall Z-1342-2016
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001
- FDA Device
- Class I
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class I recall of Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001 by Boston Scientific, citing boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the us….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1342-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-03-22 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
Reason
Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient.
Identifiers
| code_info | BATCH 129496 130473 139577 141089 141570 142212 145520 145783 148859 149263 153368 153847 154650 154786…BATCH 129496 130473 139577 141089 141570 142212 145520 145783 148859 149263 153368 153847 154650 154786 155675 155908 156690 156822 158009 158494 158598 159368 159902 160530 161209 162814 162893 162943 163987 164148 166281 166646 168472 169484 169638 170169 170464 170471 171178 171385 171800 172254 172375 172518 172831 173151 173398 173897 173902 174153 174431 174617 174619 174721 174722 174727 174728 174804 174805 175189 175190 175782 175783 176048 176221 176385 176437 176438 176843 177414 177415 177970 177971 178252 178253 178254 178764 178848 178849 178894 178935 178936 180305 180306 180367 180368 180370 180747 181168 181169 181285 181933 181934 182257 182258 182259 182927 183220 183221 183451 183452 183539 183540 183974 184091 184092 184093 184244 184245 184478 184479 184531 184532 184633 184634 185180 185182 185354 185355 185395 185396 185397 185632 185633 1 |
|---|
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-1342-2016%22
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