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U.S. Department of Health and Human Services

Class 2 Device Recall LAPBAND Adjustable Gastric Band System

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  Class 2 Device Recall LAPBAND Adjustable Gastric Band System see related information
Date Initiated by Firm September 16, 2010
Date Posted November 18, 2010
Recall Status1 Terminated 3 on December 22, 2010
Recall Number Z-0418-2011
Recall Event ID 57094
PMA Number P000008 
Product Classification Implant, intragastric for morbid obesity - Product Code LTI
Product LAP-BAND Adjustable Gastric Band System; Product codes:
B-2105 (ACCSS PRT II KIT (0-10CC) US),
B-2106 (ACCESS PRT II KIT (0-14CC) US),
B-2210 (LP-BND SYS, 9.75, STER, US),
B-2215 (LAP-BAND 9.75 W/ACC PRT II US),
B-2220 (LP-BND SYS, 10.0, STER, US),
B-2225 (LAP-BND 10.0,ACCESS PORT II,US),
B-2255 (LAP-BAND VG W/ACS PORT II (US),
B-2260 (LP-BND AP STANDARD SYS, W ACC PRT II),
B-2265 (LP-BND AP LG SYS, W/ACC PRT II);
The Lap-Band System is a long-term implantable device intended to induce weight loss in morbidly obese patients by limiting food consumption restrictive and satiating, rather than malabsorptive). The device is surgically implanted, using either a laparoscopic or open procedure, to create a restricted opening (stoma) and a small gastric pouch to limit food consumption and induce early satiety. The main components of the device are the silicone elastomer band, access port. and kink-resistant tubing used to connect the other two components. The inner surface of the silicone band, which is placed around the stomach, is inflatable and connected by the tubing to the access port (a remote injection site. The access port is implanted on, or attached to, the rectus muscle to permit non-surgical, percutaneous adjustments to the band and thus, the stoma diameter, using sterile saline.
Code Information All Lot Numbers for the listed Product Codes are affected by this recall.
Recalling Firm/
Manufacturer		 Allergan
71 S Los Carneros Rd
Goleta CA 93117-5506
For Additional Information Contact
805-683-6761
Manufacturer Reason
for Recall		 In a LAP-BAND System adjustment, failure to inject the needle perpendicular to the access port septum, as described in Directions for Use, may lead to port damage, resulting in subsequent port leakage. Leakage results in deflation of the LAP-BAND to its widest, open position requiring a procedure to replace the port. The patient may have symptoms of reduced satiety and increased appetite. Stalling
FDA Determined
Cause 2		 Pending
Action Allergan sent an URGENT FIELD CORRECTIVE ACTION letter dated September 15, 2010, to all affected customers. The recall communication was initiated on 09/16/2010 when the firm begin forwarding Customer letters with attached current Directions for Use distributed via Federal Express, with tracking verification provided by Federal Express, to the direct consignees. The Customer letters informed consignees of the products affected, description of the Issue, clinical implications and firm recommendations. Customers were instructed to follow the Directions for Use for inserting the needle. Customers were instructed to report any malfunction or adverse event related to the device to Allergan Product Support at 1-800-624-4261 ext. 5972 or 1-805-961-5972 and FDA's Medwatch Program (1-800-FDA-1088 or www.fda.gov/medwatch). For questions, consignees were instructed to contact their Allergan field representative or contact Allergan Product Support at 1-800-624-4261.
Quantity in Commerce Approx. 152,000
Distribution Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, AND WY
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.
PMA Database PMAs with Product Code = LTI and Original Applicant = ReShape Lifesciences, Inc.
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