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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88135

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

Open FDA event record

Event summary

Timeline bucket
May 28, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Heartware, Inc.

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

HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

Z-2072-2021
Recall number
Z-2072-2021
Initiated
May 28, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Heartware, Inc.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The pump has an impeller with a shroud height that did not meet the lower control limit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The pump has an impeller with a shroud height that did not meet the lower control limit.

Code information

UDI: 00888707007139. Serial Number HW42843

Distribution pattern

International distribution to the country of Germany.