FDA Device recall Z-1133-2018
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600 by Boston Scientific, citing certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1133-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-20 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Reason
Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
Identifiers
| code_info | 21071349 21186199 21264281 21338493 21072506 21186874 21264826 21339969 21097205 21189216 21268628 21346857 21099913…21071349 21186199 21264281 21338493 21072506 21186874 21264826 21339969 21097205 21189216 21268628 21346857 21099913 21192332 21269880 21348369 21101809 21194784 21275009 21348655 21104860 21196427 21279183 21351508 21106212 21196815 21280166 21354138 21111667 21197475 21282419 21355128 21112353 21198355 21284302 21356067 21120166 21201164 21285174 21359495 21121467 21203598 21285708 21360857 21125598 21204762 21287283 21361914 21129863 21207916 21291325 21366469 21134585 21210287 21291903 21368941 21136699 21212151 21295990 21372468 21139834 21215249 21301969 21373463 21143014 21216252 21302617 21373946 21 150144 21218379 21305351 21377827 21150932 21220903 21307321 21380698 21156170 21221247 21308963 21381638 21159396 21226282 21310860 21385327 211 60496 21227147 21311361 21387164 21163684 21233949 21313025 21387745 2 1164861 21235402 21313392 21391319 21165772 21237929 21315518 21393249 211 68729 21240546 21316968 21393900 21169977 21241587 21317017 2139501 |
|---|
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-1133-2018%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.