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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90913

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 05, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Datascope 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

1 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 1

LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.

Z-0131-2023
Recall number
Z-0131-2023
Initiated
August 05, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
4414 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.

Code information

UDI-DI: 10607567106571 Lot codes: 3000210759 3000210758 3000203002 3000198455 3000144227 3000142368 3000141069 3000140532 3000134522 3000130423 3000126591

Distribution pattern

No US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Pakistan, Poland, Portugal, South Korea, Russia, Spain, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay.