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Endoline PUNC

PRINCE MEDICAL · Model SN4000718 · UDI-DI 03665039001663

LTI Prescription
0
510(k) clearances
17,663
Adverse events (191 deaths)
26
Recalls
10
Facilities

Description

The deflation needle is used to drain gastric balloons

Recalls

DateFirmReason
2019-05-23Obalon Therapeutics IncDuring initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscree
2017-11-22Apollo Endosurgery IncComponent of the Lap-Band system was missing from the package
2016-10-14Reshape Medical IncReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.
2016-05-04Reshape Medical IncDue to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the result of an assembly
2014-08-15Apollo Endosurgery IncProduct was distributed past its expiration date.
2013-09-30Ethicon Endo-Surgery IncDuring aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
2013-09-30Ethicon Endo-Surgery IncDuring aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
2013-09-30Ethicon Endo-Surgery IncDuring aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
2011-03-21AllerganThe 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 seal. Consequently
2010-09-27Ethicon Endo-Surgery IncThe Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in:

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.