Animas Corporation

Reports per year

Source: FDA adverse event reports by year received, 2005–2023. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Pump, Infusion, InsulinLZG159,024
• Pump, Infusion, Insulin, To Be Used With Invasive Glucose SensorOYC39,225
• Sensor, Glucose, InvasiveMDS4,323
• Set, Administration, IntravascularFPA33
• Pump, InfusionFRN16
• System, Test, Blood Glucose, Over The CounterNBW5
• Product code ------2
• Product code 2692692
• Warmer, Thermal, Infusion FluidLGZ2
• Generator, Oxygen, PortableCAW1

Recent recalls

• 2015-01-30TerminatedSoftware design (manufacturing process)

  Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

  Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011.

• 2014-10-24TerminatedEmployee error

  Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

  Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen.

• 2014-10-24TerminatedDevice Design

  Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

  Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability.

• 2013-04-03TerminatedNonconforming Material/Component

  Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

  Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected.

• 2013-02-17TerminatedDevice Design

  Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.

  Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display.

• 2012-10-02TerminatedNonconforming Material/Component

  IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.

  Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump.

• 2012-04-06TerminatedSoftware design

  OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.

  There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not attempt to change the time or date on their pump on February 29, 2012 are not affected by this issue.

• 2011-08-12TerminatedMixed-up of materials/components

  Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.

  Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a "Replace Battery" alarm not related to the condition of the battery.

• 2011-05-10TerminatedMaterial/Component Contamination

  2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion

  Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking.

• 2010-09-10TerminatedEquipment maintenance

  One Touch Ping Glucose Management Systems Intended use: deliver insulin therapy

  sensor could be damaged