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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88369

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

Open FDA event record

Event summary

Timeline bucket
July 23, 2021
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

TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

Z-2327-2021
Recall number
Z-2327-2021
Initiated
July 23, 2021
Classification
Class II
Status
Ongoing
Quantity
4980 sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for leaks and loosening at the patient catheter connection

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for leaks and loosening at the patient catheter connection

Code information

GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.

device · product 2 of 2

TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

Z-2328-2021
Recall number
Z-2328-2021
Initiated
July 23, 2021
Classification
Class II
Status
Ongoing
Quantity
4200 sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for leaks and loosening at the patient catheter connection

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for leaks and loosening at the patient catheter connection

Code information

GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.