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Terminated

Medtronic Midas Rex Legend High Speed Pneumatic System

FDA Recall Z-0278-05 · Posted 2004-12-04

Recalling FirmPower Surgical Solutions
Recall StatusTerminated
Product CodeHBB
Date Initiated2004-11-11
Date Terminated2005-09-20
Product Quantity1432 units

Reason for Recall

Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. Complaints of hose rupture/burst have been reported.

Firm Action

The firm initiated the recall via letter on November 11, 2004.

Root Cause

Other

Distribution Pattern

Nationwide and to the following foreign countries; Australia; Japan; Canada, China; Netherlands; Columbia; Mexico; Argentina; Sweden; Poland; Spain; Germany; Great Britan; Chile; Switzerland; Venezuela

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020069MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEMMedtronic Midas Rex · 2002-03-18

Official Source

View FDA Recall →

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

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