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U.S. Department of Health and Human Services

Class 2 Device Recall LapBand AP System

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  Class 2 Device Recall LapBand AP System see related information
Date Initiated by Firm August 15, 2014
Date Posted September 30, 2014
Recall Status1 Terminated 3 on February 01, 2016
Recall Number Z-2732-2014
Recall Event ID 69132
Product Classification Implant, intragastric for morbid obesity - Product Code LTI
Product LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes.

The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.
Code Information Lap-Band System AP Standard Catalog Number B-2240; Serial Numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, 17704653
Recalling Firm/
Manufacturer		 Apollo Endosurgery Inc
1120 S Capital Of Texas Hwy
Bldg. 1, Ste. 300
West Lake Hills TX 78746-6464
For Additional Information Contact Ron Lagerquist
805-319-5260
Manufacturer Reason
for Recall		 Product was distributed past its expiration date.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action Firm called its consignees and advised them to either return or destroy the devices which had not already been implanted.
Quantity in Commerce 10
Distribution Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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