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Terminated

ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.

FDA Recall Z-1315-04 · Posted 2004-08-07

Recalling FirmDatascope Interventional Products Division
Recall StatusTerminated
Product CodeMCW
Date Initiated2004-07-12
Date Terminated2004-11-22
Product Quantity892

Reason for Recall

The motor may fail to activate when the on/off switch is pressed.

Firm Action

Letter dated July 16, 2004 was mailed via US mail, return receipt requested.

Root Cause

Other

Distribution Pattern

The product was shipped nationwide to 243 direct accounts. and to 7 government accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031610REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEMRex Medical · 2003-05-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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