Skip to content

HALO Flex Energy Generators recallZ-2379-2012 · Covidien LLC · initiated Aug 3, 2012

Class II Terminated All recalls posted in September 2012

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 Covidien LLC 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

Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.

FDA root cause category: Software design

What the company is doing

COVIDIEN sent an Urgent Medical Device Correction letter dated August 3, 2012, to all affected customers via Federal Express. Additionally, Field Service Representatives will be contacting their accounts to notify them of the correction.. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following steps prior to initiating patient treatment and specifically, prior to administering conscious sedation and performing upper endoscopy: 1. Power-on the HALO Flex Energy Generator and confirm that the generator passes self-test, enters standby mode and displays "Ready, Connect Catheter." 2. Confirm that the HALO Flex Energy Generator is functioning properly at power-up and enters the standby mode then the procedure can begin. 3. Do not use the HALO Flex Energy Generator if the generator does not pass the power on self-test. In this situation, please call Covidien, GI Solutions customer service at (888) 662-2779 or your local territory manager (sales representative) so that the firm can provide them with a replacemenent generator. 4. Customers were asked to reply to Covidien, GI Solutions (formerly BARRX Medical) by signing and returning the attached Product Correction Form via fax to the number provided on the form. Customers with questions were instructed to call 888-662-2779. For questions regarding this recall call 408-328-7300.

Recall details

Recall number
Z-2379-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 3, 2012
Posted by the FDA
Sep 14, 2012
Recalling firm
Covidien LLC
Quantity
617 generators
Product code
GEI
FDA submissions
K092487
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Jordan, Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Venezuela and UK.

Product description

HALO Flex Energy Generators Manufactured by BRRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, including Barrett's Esophagus.

Code information (models, lots, serial numbers)

Model numbers 1190A-115A and 1190A-230A; all serial numbers.

Other devices under the same FDA submission

1 device cleared under K092487 — 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

How recalls are matched to devices · Editorial policy · Report an error on this page