Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to facilitate manipulation, positioning and control for collecting electrophysiological data within the heart atria.
FDA Recall Z-2106-2008 · Posted 2008-09-11
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Recalling FirmHansen Medical Inc
Recall StatusTerminated
Product CodeDRA
Date Initiated2008-05-21
Date Terminated2009-05-27
Product Quantity369 units
Reason for Recall
The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of hemostasis, flush fluid leakage, and/or introduction of air into the catheter with a risk of subsequent embolism.
Firm Action
On May 21, 2008 an Urgent: Voluntary Product Recall Notification was issued. All customers who received affected product were verbally contacted directly by the firm, and were sent a follow up letter, asking them to segregate the product. Replacements will be shipped to them. If you have questions please contact Doug Worth at 1-650-404-5940.
Root Cause
Device Design
Distribution Pattern
Class II Recall - Worldwide Distribution ---- including USA and countries of UK, Italy, Germany, and Czech Republic.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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