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MEDTRONIC, INC. · Model 1035E · UDI-DI 00763000306571
LPB
Prescription
0
510(k) clearances
16,442
Adverse events (724 deaths)
21
Recalls
56
Facilities
Description
HOSE 1035E SCAVENGING 9M 30FT YELLOW MDR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-09-06 | Biosense Webster, Inc. | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand cathet |
| 2017-09-06 | Biosense Webster, Inc. | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand cathet |
| 2017-09-06 | Biosense Webster, Inc. | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand cathet |
| 2017-09-06 | Biosense Webster, Inc. | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand cathet |
| 2017-09-06 | Biosense Webster, Inc. | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand cathet |
| 2017-06-14 | Biosense Webster, Inc. | Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets. |
| 2015-09-01 | Medtronic Inc. Cardiac Rhythm Disease Management | An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time. |
| 2014-10-19 | Biosense Webster, Inc. | The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter. |
| 2011-07-07 | Biosense Webster, Inc. | Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio Frequency Generator, to communicate undetected software anomalies in th |
| 2011-02-10 | St Jude Medical | The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions f |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.