EasyMap MAP L (80mm)
MedFact Engineering GmbH · Model MF0010 · UDI-DI 04260192832124
Description
EasyMap MAP is a temporary quadropolar Catheter for recording monophasic action potentials and for intracardial pacing. Integrated in the tip of the lead are a Silver-Chloride Electrode (AgCl), a Silver Electrode (Ag) and in addition two orthogonal placed Silver Electrodes (Ag). The catheter can be introduced and positioned in the required area with the means of a suitable guiding system. The catheter has a good torque and is deflectable. By pushing the distal part of the handle the catheter tip can be deflected without jerk and infinitely variable in a steady position. The deflection of the catheter tip is effected proportional to the movement of the distal part of the handle. The once reached position then remains stable. The size of the deflection depends on the different lengths of the flexible catheter tip.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-24 | Irvine Biomedical Inc, a St. Jude Medical Co. | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 |
| 2020-08-24 | Irvine Biomedical Inc, a St. Jude Medical Co. | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 |
| 2018-07-30 | Arrow International Inc | Products are labeled with an incorrect expiration date |
| 2015-09-29 | Medtronic Inc. | 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. |
| 2015-04-17 | Biosense Webster, Inc. | The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System. |
| 2015-02-25 | Biosense Webster, Inc. | Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover. |
| 2014-11-20 | Boston Scientific Corp | Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field |
| 2014-10-14 | St Jude Medical | St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identi |
| 2013-06-19 | Biosense Webster, Inc. | Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Cathe |
| 2011-05-23 | Biosense Webster, Inc. | The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to th |
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