Animas Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 71
- FDA recalls
- 28
At a glance
Market reach
- United States
- FDA recalls
What Animas Corp. makes
Animas Corp. manufactures insulin infusion pumps, including the R1000 series and Model IR1200/IR1250, designed for continuous subcutaneous insulin delivery. Their portfolio also includes infusion sets like the EZ SET and Animus EZSERter, as well as diabetes management software such as EZManager Max and Symphony for glucose monitoring. Additional products include the GlucoWatch automatic glucose biographer and the Animas Vibe system for integrated diabetes care.
The company’s devices are regulated under FDA pathways, with Class II and Class III classifications. Products are authorised via 510(k) clearances and Premarket Approval (PMA) applications. Animas Corp. is based in the United States.
Catalogue
Search and filter all 71 devicesShowing 1-50 of 71
FDA recalls
2014
- 10 Jun 2014 Z-0136-2015 Class II Terminated 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.
2013
- 3 Jan 2013 Z-0993-2013 Class I Terminated 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.
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- 3 Jan 2013 Z-0993-2013 Class I Terminated 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.
2012
- 17 Dec 2012 Z-0836-2013 Class III Terminated 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.
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- 25 Oct 2012 Z-0137-2015 Class II Terminated 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.
- 16 Jul 2012 Z-0005-2013 Class II Terminated Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump.
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- 1 Mar 2012 Z-1376-2012 Not yet classified Terminated 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.
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- 17 Dec 2012 Z-0836-2013 Class III Terminated 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.
2011
- 6 Sep 2011 Z-1034-2015 Class II Terminated 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.
- 29 Jul 2011 Z-3017-2011 Unclassified (pre-2012) Terminated 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.
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- 25 Feb 2011 Z-1678-2011 Unclassified (pre-2012) Terminated 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
- 18 Mar 2010 Z-2394-2010 Unclassified (pre-2012) Terminated sensor could be damaged
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- 18 Mar 2010 Z-2394-2010 Unclassified (pre-2012) Terminated sensor could be damaged
Show the 25 most recent of 28 recalls
2010
- 18 Mar 2010 Z-2395-2010 Unclassified (pre-2012) Terminated sensor could be damaged
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- 18 Mar 2010 Z-2396-2010 Unclassified (pre-2012) Terminated sensor could be damaged
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- 18 Mar 2010 Z-2397-2010 Unclassified (pre-2012) Terminated sensor could be damaged
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- 18 Mar 2010 Z-2395-2010 Unclassified (pre-2012) Terminated sensor could be damaged
2009
- 18 Dec 2009 Z-1560-2010 Unclassified (pre-2012) Terminated Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food database and pump settings using the software.
- 2 Nov 2009 Z-0481-2010 Unclassified (pre-2012) Terminated Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.
2008
- 27 Oct 2008 Z-0955-2009 Unclassified (pre-2012) Terminated incorrect dosing recommendation
- 4 Aug 2008 Z-0283-2009 Unclassified (pre-2012) Terminated display old, inaccurate values for bolus amount delivered and amount of planned bolus totals
- 4 Aug 2008 Z-0290-2009 Unclassified (pre-2012) Terminated Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
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- 4 Aug 2008 Z-0291-2009 Unclassified (pre-2012) Terminated Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
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- 4 Aug 2008 Z-0292-2009 Unclassified (pre-2012) Terminated Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
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- 4 Aug 2008 Z-0293-2009 Unclassified (pre-2012) Terminated Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
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- 4 Aug 2008 Z-0294-2009 Unclassified (pre-2012) Terminated Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
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2005
- 31 Oct 2005 Z-0306-06 Unclassified (pre-2012) Terminated Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
- 31 Oct 2005 Z-0307-06 Unclassified (pre-2012) Terminated Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
- 31 Oct 2005 Z-0308-06 Unclassified (pre-2012) Terminated Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
Frequently asked questions
How many devices does Animas Corp. have in the registry?
The registry currently lists 71 devices for Animas Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Animas Corp.'s devices?
Among its 50 most recently registered devices, Animas Corp. has devices listed in FDA GUDID (50 devices).
What risk classes do Animas Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Animas Corp.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Animas Corp.?
FDA recall records list 28 recalls initiated by Animas Corp., the most recent initiated on 2014-06-10. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Animas Corp. in the registry?
The most recently registered devices listed for Animas Corp. include OneTouch Ping 10143100, Animas Vibe 11851200, Animas Vibe 11551200 and Animas Vibe 10255100.