Reported Jun 24, 2020 · Terminated
PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster…
Biosense Webster
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BIOSENSE WEBSTER · 33 TECHNOLOGY DRIVE · IRVINE, CA · 92618
Is this the product you have?
- PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22
- Rx only STERILE EO - Product UsageThe Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart
- Lot codes and dates
- PENTARAY
- NAV eco High-Density Mapping CatheterAll
- Lots of the following product codesD-1282-07, D-1282-08, D-1282-10 and D-1282-11 Product Code Product Description GTIN Number D-1282-07-S PENTARAY¿ NAV ECO 7FR, F, 4-4-4 10846835012217 Lot NumberPENTARAY¿ NAV ECO 7FR, F, 2-6-2 10846835012224 Lot Number
30001176L30003606L30003607L30001016L30001251L17625708L30005207L30005537L30005089L30005206L30166349L30166345L30166346L30166347L30166348L30166351L17393341L17630191L17630192L17630193L17393342L17393343L17395423L17630194L17395888L17397254L17393340L30338080L30338081L30009837L30166350L30338079L17633498L17633500L30009839L30009842L30009843L30009844L30345912L17633499L30009838L30009841L30011828L30011829L30011830L30011831L30345911L30345913L17403221L17404168L17404171L30173420LD-1282-08-S
2,877 of 2,877 codes
17626989L17626993L17626995L17626998L17626991L17626992L17626999L17627001L17627002L17627004L30155766L30155767L30155769L30155773L30155778L30161076L30161087L30161091L30161095L30161096L30163666L30163668L30163674L30164145L30164147L17388298L17388451L17388452L17626996L17626997L17627000L17627094L17627096L17627097L17627098L17627099L17627101L17627102L17627103L17627104L17627105L17627106L17627107L30001259L30001261L30003199L30003200L30003202L30003204L30003208L30003209L30003210L30003211L30003212L30003214L30003216L30003217L30155469L30155765L30155768L
- Amount recalled
- 435590 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
This product could cause temporary or reversible health problems — stop using it.
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