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U.S. Department of Health and Human Services

Class 2 Device Recall Apollo LapBand AP System Small with RapidPort EZ

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 Class 2 Device Recall Apollo LapBand AP System Small with RapidPort EZsee related information
Date Initiated by FirmNovember 22, 2017
Create DateAugust 10, 2018
Recall Status1 Terminated 3 on October 06, 2020
Recall NumberZ-2743-2018
Recall Event ID 80079
PMA NumberP000008 
Product Classification Implant, intragastric for morbid obesity - Product Code LTI
ProductApollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the access port. The band is placed laparoscopically around the stomach, creating a small pouch or stoma, thereby limiting food consumption. The band can be inflated or deflated with saline, through the access port, depending on patient needs and progress. The Lap-Band access port is a low-profile cylindrical port attached to kink-resistant tubing . The port is implanted subcutaneously or in the rectus muscle and can be penetrated in its silicone septum by a non-coring needle to inject or remove saline into or from the band. The kink-resistant tubing connects the access port to the band.
Code Information Item Lot # Serial # C-2306 AF00921 S0034428 C-2306 AF00921 S0034429 C-2306 AF00921 S0034430 C-2306 AF00921 S0034431 C-2306 AF00921 S0034433 C-2306 AF00921 S0034435 C-2306 AF00921 S0034437 C-2306 AF00921 S0034439 C-2306 AF00921 S0034441 C-2306 AF00921 S0034443 C-2306 AF00921 S0034445 C-2306 AF00921 S0034447 C-2306 AF00921 S0034449 C-2306 AF00921 S0034450 C-2306 AF00921 S0034451 C-2306 AF00921 S0034453 C-2306 AF00921 S0034455 C-2306 AF00921 S0034457 C-2306 AF00921 S0034440 C-2306 AF00921 S0034433 C-2306 AF00921 S0034450 C-2306 AF00921 S0034434 C-2306 AF00921 S0034436 C-2306 AF00921 S0034438 C-2306 AF00921 S0034444 C-2306 AF00921 S0034446 C-2306 AF00921 S0034448 C-2306 AF00921 S0034452 C-2306 AF00921 S0034454 C-2306 AF00921 S0034456 C-2306 AF00921 S0034442 C-2306 AF00921 S0034432 C-20360 AF00929 S0034459 C-20360 AF00929 S0034460 C-20360 AF00929 S0034461 C-20360 AF00929 S0034463 C-20360 AF00929 S0034464 C-20360 AF00929 S0034466 C-20360 AF00929 S0034467 C-20360 AF00929 S0034468 C-20360 AF00929 S0034469 C-20360 AF00929 S0034470 C-20360 AF00929 S0034472 C-20360 AF00929 S0034473 C-20360 AF00929 S0034460 C-20360 AF00929 S0034465 C-20360 AF00929 S0034480 C-20360 AF00929 S0034486 C-20360 AF00929 S0034467 C-20360 AF00929 S0034469 C-20360 AF00929 S0034473 C-20360 AF00929 S0034458 C-20360 AF00929 S0034462 C-20360 AF00929 S0034471 C-20360 AF00929 S0034474 C-20360 AF00929 S0034475 C-20360 AF00929 S0034476 C-20360 AF00929 S0034477 C-20360 AF00929 S0034478 C-20360 AF00929 S0034479 C-20360 AF00929 S0034481 C-20360 AF00929 S0034482 C-20360 AF00929 S0034483 C-20360 AF00929 S0034484 C-20360 AF00929 S0034485 C-20360 AF00929 S0034487  
Recalling Firm/
Manufacturer		 Apollo Endosurgery Inc
1120 S Capital Of Texas Hwy Ste 1
300
West Lake Hills TX 78746-6464
For Additional Information Contact
512-279-5100
Manufacturer Reason
for Recall		Component of the Lap-Band system was missing from the package
FDA Determined
Cause 2		Under Investigation by firm
ActionConsignees were initially contacted via telephone and later via letter. The firms letter requested the hospital risk manager dispose of the defective product.
Quantity in Commerce54
DistributionWorldwide Distribution - FL, IL, LA, MI, MO, NC, NY, TN, TX, VA and WV and the countries of France, Italy, Spain, and United Kingdom
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LTI
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