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Recall Observatory FDA recall evidence

Device product

WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)

Z-1593-2023

April 05, 2023

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 92072
Status
Ongoing
Classification
Class II
Quantity
10833 units
Official record key
device-enforcement:Z-1593-2023

Official wording

Reason: The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

Code information: 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

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.