International safety notice

Urgent Field Safety Notice for BIB/Orbera/Orbera365 Intragastric Balloon Systems by apollo endosurgery

Germany / BfArM · DEU · Jul 27, 2021

Key facts

Title Urgent Field Safety Notice for BIB/Orbera/Orbera365 Intragastric Balloon Systems by apollo endosurgery
Regulator Germany / BfArM
Country DEU
Brand BIB/Orbera/Orbera365 Intragastric Balloon Systems
Manufacturer apollo endosurgery
Models B-50000, B-40800, FSCA-20-002, 12-MONTH, HERE1, FSCA-20-002-INTRAGASTRIC-BALLOONS, ORBERA365, B-50012, PMA_PAS.CFM?T_ID=534908&C_ID=3558
Date Jul 27, 2021
Regulator page bfarm.de

At a glance

  • No Recall
  • No Field safety notice

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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