FDA Device recall Z-1593-2023
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
- FDA Device
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package) by Boston Scientific, citing the firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1593-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-05 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Reason
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Identifiers
| code_info | GTIN 08714729965770 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30319836,30359588,30368418,30…GTIN 08714729965770 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30319836,30359588,30368418,30392647,30409465,30421836, 30442123,30522919,30564343,30577971,30593836,30600837, 30600839,30601021,30616553,30620297,30625219,30638465, 30638467,30638469,30638471,30665570,30666996,30681966, 30681968,30681970,30712588,30725194,30780665,30801487, 30801489,30801491,30811488,30845828,30845830,30845832, 30885087,30890263,30890265,30914070,30922072,30929565, 30935495,30935497,30935499,30981820 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1593-2023%22
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