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LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port recallZ-0070-2012 · Lemaitre Vascular, Inc. · initiated Oct 4, 2011

Terminated All recalls posted in October 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Lemaitre Vascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Extended Expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05

FDA root cause category: Incorrect or no expiration date

What the company is doing

The firm, LeMaitre Vascular, Inc., sent an "URGENT: 9F PRUITT F3 Carotid Shunt Device Field Safety Notice" dated October 4, 2011 to its customers. The notice describes the product, problem and action to be taken. The customers were instructed to identify their inventory; return the affected products for exchange with a properly labeled device; contact Le Matire customer service for replacement at 800-628-9470, and complete and return the RECALL NOTICE RECONCILIATION FORM via fax to 781-425-5049, even if no product is on hand. If you have any questions concerning this safety notice, please contact the Quality Assurance Engineer at 781-221-2266 ext. 183.

Recall details

Recall number
Z-0070-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 4, 2011
Posted by the FDA
Oct 19, 2011
Recalling firm
Lemaitre Vascular, Inc.
Quantity
144 units
Product code
MJN
FDA submissions
K051067
Distribution
Nationwide distribution: USA including states of: CA, FL, IA, IL, MA, MI, NE, NJ, NY, OH, SC, TX, and WI.

Product description

LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the Shunt when it is placed within the common and internal carotid arteries. An external safety balloon located on the inflation arm leading to the distal (internal carotid) balloon acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above optimal size and pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage. The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The sleeve of the external safety balloon is yellow, to increase its visibility. Depth markings on the shunt body are for reference during insertion

Code information (models, lots, serial numbers)

Lot Number: PFT2209

Other devices under the same FDA submission

10 devices cleared under K051067 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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