LAP-BAND Adjustable Gastric Band System; Product codes: B-2105 (ACCSS PRT II KIT (0-10CC) US), B-2106 (ACCESS PRT II KIT

FDA device recall Z-0418-2011 · posted 2010-11-18 · Terminated

Recall details

Recalling firm

Allergan

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

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

LTI

Quantity affected

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

Date initiated

2010-09-16

Date posted

2010-11-18

Date terminated

2010-12-22

Location

Goleta, CA