Disetronic Medical Systems
Country not established
- Devices
- 29
- FDA recalls
- 33
At a glance
Market reach
- United States
- FDA recalls
What Disetronic Medical Systems makes
Disetronic Medical Systems manufactures insulin infusion pumps, including programmable and reusable models like the D-Tron and H-Tron V 100, as well as insulin injection pens and pen needles such as the Penfine. The company also produces infusion pump systems like the Multifuse and standalone insulin delivery devices, including the Infusor and Dolomat pump.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with several authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the company is based in the United States.
Catalogue
Search and filter all 29 devicesFDA recalls
FDA recall records list 33 recalls initiated by Disetronic Medical Systems, the earliest on 2006-03-31 and the most recent on 2009-04-30. By recorded status: 33 terminated. The reasons filed fall into these groups: electrical or power and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 30 Apr 2009 Z-1646-2009 Unclassified (pre-2012) Terminated The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.
2006
- 13 Jul 2006 Z-1413-06 Unclassified (pre-2012) Terminated The battery may turn the pump off without warning due to a design change in the battery.
- 31 Mar 2006 Z-1116-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1117-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1118-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1119-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1120-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1121-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1122-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1123-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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Show the 25 most recent of 33 recalls
2006
- 31 Mar 2006 Z-1124-06 Unclassified (pre-2012) Terminated The luer tube may break at the connection to the pump and, if this is not noticed by the patient, the patient may receive an under delivery of insulin.
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- 31 Mar 2006 Z-1125-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1126-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1127-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1128-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1129-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1130-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1131-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1132-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1133-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1134-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1135-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1136-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1137-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1138-06 Unclassified (pre-2012) Terminated The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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- 31 Mar 2006 Z-1124-06 Unclassified (pre-2012) Terminated The luer tube may break at the connection to the pump and, if this is not noticed by the patient, the patient may receive an under delivery of insulin.
Frequently asked questions
How many devices does Disetronic Medical Systems have in the registry?
The registry currently lists 29 devices for Disetronic Medical Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Disetronic Medical Systems's devices?
Among its 29 most recently registered devices, Disetronic Medical Systems has devices listed in FDA 510(k) (29 devices).
What risk classes do Disetronic Medical Systems's devices fall under?
Among its 29 most recently registered devices, the classes recorded for Disetronic Medical Systems's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Disetronic Medical Systems?
FDA recall records list 33 recalls initiated by Disetronic Medical Systems, the most recent initiated on 2009-04-30. 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 Disetronic Medical Systems in the registry?
The most recently registered devices listed for Disetronic Medical Systems include DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET, MODIFICATION TO D-TRONPLUS, MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP and DISETRONIC D-MODEM.