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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92072

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 05, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)

Z-1592-2023
Recall number
Z-1592-2023
Initiated
April 05, 2023
Classification
Class II
Status
Ongoing
Quantity
1300 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565

Distribution pattern

Worldwide

device · product 2 of 2

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

Z-1593-2023
Recall number
Z-1593-2023
Initiated
April 05, 2023
Classification
Class II
Status
Ongoing
Quantity
10833 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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