Home › Device types › LTI
Implant, Intragastric For Morbid Obesity
FDA product code LTI · Class 3 · Unknown
78
Registered devices
17,663
Adverse events
26
Recalls
0
510(k) clearances
Devices with this code
LAP-BAND® AP System Large with RapidPort® EZ — Medtimo, IncReShape Lap-Band® 2.0, FLEX & Access Port, Large — Medtimo, IncReShape Lap-Band® 2.0 FLEX, Standard — Medtimo, IncLAP-BAND System Access Port II Kit — Apollo Endosurgery, Inc.OBALON® Balloon Kit — Medtimo, IncLAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ — Apollo Endosurgery, Inc.RapidPort EZ — Apollo Endosurgery, Inc.ReShape Lap-Band® 2.0 FLEX, Large — Medtimo, IncAccess Port RapidPort EZ Kit — Apollo Endosurgery, Inc.OBALON® — Medtimo, IncNA — Obtech Medical SàrlLAP-BAND System Access Port I Kit — Apollo Endosurgery, Inc.LAP-BAND Calibration Tube — Apollo Endosurgery, Inc.LAP-BAND AP Adjustable Gastric Banding System — Apollo Endosurgery, Inc.OBALON® EzFill™ Can — Medtimo, IncReShape™ Valve Sealant — RESHAPE MEDICAL, INC.ReShape Lap-Band® 2.0, FLEX & Access Port, Standard — Medtimo, IncSpatz3 Adjustable Balloon System insertion kit — SPATZ FGIA (ISRAEL) LTDExtraction Kit — PRINCE MEDICALOBALON® — Medtimo, IncLAP-BAND — Apollo Endosurgery, Inc.ORBERA Intragastric Balloon System — Apollo Endosurgery, Inc.The LAP-BAND Adjustable Gastric Banding System — Apollo Endosurgery, Inc.The LAP-BAND Adjustable Gastric Banding System — Apollo Endosurgery, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-23 | Obalon Therapeutics Inc | During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occ |
| 2017-11-22 | Apollo Endosurgery Inc | Component of the Lap-Band system was missing from the package |
| 2016-10-14 | Reshape Medical Inc | ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation. |
| 2016-05-04 | Reshape Medical Inc | Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the r |
| 2014-08-15 | Apollo Endosurgery Inc | Product was distributed past its expiration date. |
| 2013-09-30 | Ethicon Endo-Surgery Inc | During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. |
| 2013-09-30 | Ethicon Endo-Surgery Inc | During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. |
| 2013-09-30 | Ethicon Endo-Surgery Inc | During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. |
| 2011-03-21 | Allergan | The recall was initiated because Allergan has determined that a number of Access Port Needle pouches from one specific lot number may have small gaps in a pouch |
| 2010-09-27 | Ethicon Endo-Surgery Inc | The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. |
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