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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83895

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

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Event summary

Timeline bucket
August 22, 2019
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Thoratec Switzerland GMBH

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

CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.

Z-0221-2020
Recall number
Z-0221-2020
Initiated
August 22, 2019
Classification
Class I
Status
Terminated
Recalling firm
Thoratec Switzerland GMBH
Quantity
664 units (381 U.S. and 283 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

Code information

U.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024

Distribution pattern

Distribution was nationwide. There was government distribution, but no military distribution. Foreign distribution was made to Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, France, Hong Kong, India, Israel, Italy, Liechtenstein, Mexico, Netherlands, Portugal, Qatar, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.