Medtronic Physio-Control Corp.
United StatesFDA applicant, unverified
- Devices
- 8
- FDA recalls
- 7
At a glance
Market reach
- United States
- FDA recalls
What Medtronic Physio-Control Corp. makes
The company manufactures automated external defibrillators (AEDs), including standalone and semi-automated models like the LIFEPAK 600 and modifications to the LIFEPAK 500, as well as advanced defibrillator/monitor systems such as the LIFEPAK 12 and LIFEPAK 20. These devices also incorporate pacemaker capabilities in select models and feature infant/child reduced-energy electrodes for pediatric use. The portfolio includes both portable and semi-portable defibrillator/monitor systems for emergency and clinical settings.
The devices fall under FDA Class II and Class III classifications, with regulatory authorisation supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Lifepak 12 Defibrillator/Monitor System Ref K010918
Regimes: 510(k) Registry: 510(k)Lifepak 12 Ref K040775
Regimes: 510(k) Registry: 510(k)Lifepak 600 Automated External Defibrillator Ref K011144
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Lifepak 12DEFIBERLLATOR/Monitor Series Ref K002445
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Lifepak 12, 20, 500, Cr Plus Ref K033275
Regimes: 510(k) Registry: 510(k)Infant/Child Reduced Energy Electrodes Ref K022732
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 7 recalls initiated by Medtronic Physio-Control Corp., the earliest on 2003-01-27 and the most recent on 2004-05-05. By recorded status: 7 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 5 May 2004 Z-0971-04 Unclassified (pre-2012) Terminated The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor.
- 5 May 2004 Z-1107-04 Unclassified (pre-2012) Terminated Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ECG monitoring, external pacing or defibrillation; ECG connector with higher than normal connection resistance resulting in intermittent ECG signal; therapy connector has potential for impact damage.
Full distribution text
- 5 Apr 2004 Z-0938-04 Unclassified (pre-2012) Terminated Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.
Full distribution text
- 2 Apr 2004 Z-0886-04 Unclassified (pre-2012) Terminated Potential for batteries to malfunction due to battery cell rupture.
Full distribution text
2003
- 12 Nov 2003 Z-0294-04 Unclassified (pre-2012) Terminated Device unable to recognize the connection to the hard paddles accessory.
- 23 May 2003 Z-0940-03 Unclassified (pre-2012) Terminated Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
Full distribution text
- 27 Jan 2003 Z-0542-03 Unclassified (pre-2012) Terminated Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.
Frequently asked questions
How many devices does Medtronic Physio-Control Corp. have in the registry?
The registry currently lists 8 devices for Medtronic Physio-Control Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Physio-Control Corp.'s devices?
Among its 8 most recently registered devices, Medtronic Physio-Control Corp. has devices listed in FDA 510(k) (8 devices).
What risk classes do Medtronic Physio-Control Corp.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Medtronic Physio-Control Corp.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Medtronic Physio-Control Corp.?
FDA recall records list 7 recalls initiated by Medtronic Physio-Control Corp., the most recent initiated on 5 May 2004. 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 Medtronic Physio-Control Corp. in the registry?
The most recently registered devices listed for Medtronic Physio-Control Corp. include LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM, LIFEPAK 12, LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR and MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR.