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Terminated

Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.

FDA Recall Z-2450-2012 · Posted 2012-09-25

Recalling FirmAbbott Vascular
Recall StatusTerminated
Product CodeLIT
Date Initiated2012-08-20
Date Terminated2013-07-15
Product Quantity61,799 units

Reason for Recall

Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.

Firm Action

An "Urgent Device Recall" letter dated 8/20/2012 was sent to all customers who purchased the Armada 35 and Armada 35 LL PTA Catheters. The letter informed the customers of the problem identified and the action to be taken. A list of lot numbers and an effectiveness check form was sent to customers with the customer notification letter. Customers were instructed to call Abbott Vascular Customer Service at (800) 227-9902.

Root Cause

Process design

Distribution Pattern

Nationwide(US) Distribution and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111899ARMADA 35/35LL PTA CATHETERAbbott Vascular · 2011-10-03

Official Source

View FDA Recall →

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

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