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U.S. Department of Health and Human Services

Class 2 Device Recall Solarice Rapid Exchange Balloon Dilatation Catheter

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  Class 2 Device Recall Solarice Rapid Exchange Balloon Dilatation Catheter see related information
Date Initiated by Firm September 03, 2019
Create Date October 11, 2019
Recall Status1 Open3, Classified
Recall Number Z-0123-2020
Recall Event ID 83797
Product Classification Catheters, Transluminal Coronary Angioplasty, Percutaneous - Product Code LOX
Product Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)
Code Information Product Number / CFN GTIN Lot SLC1506X 00643169680005 217427355 SLC1510X 00643169680012 217253572 SLC1510X 00643169680012 217298666 SLC1510X 00643169680012 217387126 SLC1510X 00643169680012 217427354 SLC1510X 00643169680012 217487816 SLC1512X 00643169680029 217218112 SLC1512X 00643169680029 217253582 SLC1512X 00643169680029 217387128 SLC1512X 00643169680029 217487818 SLC1512X 00643169680029 217542634 SLC1512X 00643169680029 217859789 SLC1515X 00643169680036 217246455 SLC1515X 00643169680036 217253577 SLC1515X 00643169680036 217306789 SLC1515X 00643169680036 217415822 SLC1515X 00643169680036 217427365 SLC1515X 00643169680036 217823443 SLC1515X 00643169680036 217859165 SLC1515X 00643169680036 217940024 SLC1520X 00643169680043 217253580 SLC1520X 00643169680043 217306787 SLC1520X 00643169680043 217427359 SLC1520X 00643169680043 217542633 SLC1520X 00643169680043 217646425 SLC1520X 00643169680043 217668582 SLC1520X 00643169680043 217799249 SLC1520X 00643169680043 217859164 SLC2006X 00643169680050 217435326 SLC2006X 00643169680050 217913786 SLC2010X 00643169680067 217253573 SLC2010X 00643169680067 217297545 SLC2010X 00643169680067 217387127 SLC2010X 00643169680067 217427356 SLC2010X 00643169680067 217646867 SLC2010X 00643169680067 217668585 SLC2010X 00643169680067 217676631 SLC2010X 00643169680067 217905820 SLC2012X 00643169680074 217253578 SLC2012X 00643169680074 217298670 SLC2012X 00643169680074 217306788 SLC2012X 00643169680074 217415824 SLC2012X 00643169680074 217434925 SLC2012X 00643169680074 217602539 SLC2012X 00643169680074 217668687 SLC2012X 00643169680074 217799250 SLC2012X 00643169680074 217859791 SLC2012X 00643169680074 217940066 SLC2015X 00643169680081 217218115 SLC2015X 00643169680081 217253574 SLC2015X 00643169680081 217271254 SLC2015X 00643169680081 217298669 SLC2015X 00643169680081 217306223 SLC2015X 00643169680081 217404046 SLC2015X 00643169680081 217418812 SLC2015X 00643169680081 217418907 SLC2015X 00643169680081 217427706 SLC2015X 00643169680081 217435327 SLC2015X 00643169680081 217498815 SLC2015X 00643169680081 217615647 SLC2015X 00643169680081 217646871 SLC2015X 00643169680081 217668584 SLC2015X 00643169680081 217713076 SLC2015X 00643169680081 217721607 SLC2015X 00643169680081 217777612 SLC2015X 00643169680081 217799251 SLC2015X 00643169680081 217884509 SLC2015X 00643169680081 217913790 SLC2020X 00643169680098 217218110 SLC2020X 00643169680098 217246457 SLC2020X 00643169680098 217253575 SLC2020X 00643169680098 217271253 SLC2020X 00643169680098 217298667 SLC2020X 00643169680098 217306220 SLC2020X 00643169680098 217387130 SLC2020X 00643169680098 217404047 SLC2020X 00643169680098 217418908 SLC2020X 00643169680098 217487822 SLC2020X 00643169680098 217498821 SLC2020X 00643169680098 217676628 SLC2020X 00643169680098 217713075 SLC2020X 00643169680098 217727927 SLC2020X 00643169680098 217799252 SLC2020X 00643169680098 217850364 SLC2020X 00643169680098 217905822 SLC2025X 00643169680104 217271251 SLC2025X 00643169680104 217542635 SLC2025X 00643169680104 217905821 SLC2030X 00643169680111 217218119 SLC2030X 00643169680111 217427363 SLC2030X 00643169680111 217602538 SLC2030X 00643169680111 217704778 SLC2030X 00643169680111 217777614 SLC22510X 00643169680135 217487815 SLC22510X 00643169680135 217646423 SLC22515X 00643169680159 217427362 SLC22515X 00643169680159 217646422 SLC22520X 00643169680166 217721606 SLC22520X 00643169680166 217913787 SLC22525X 00643169680173 217415820 SLC22525X 00643169680173 218025488 SLC2506X 00643169680180 217823441 SLC2510X 00643169680197 217218122 SLC2510X 00643169680197 217401003 SLC2510X 00643169680197 217427357 SLC2510X 00643169680197 217693881 SLC2510X 00643169680197 217913792 SLC2510X 00643169680197 218034774 SLC2512X 00643169680203 217271257 SLC2512X 00643169680203 217306225 SLC2512X 00643169680203 217415825 SLC2512X 00643169680203 217434924 SLC2512X 00643169680203 217498822 SLC2512X 00643169680203 217606584 SLC2512X 00643169680203 217695006 SLC2512X 00643169680203 217859787 SLC2512X 00643169680203 217913793 SLC2515X 00643169680210 217253581 SLC2515X 00643169680210 217306786 SLC2515X 00643169680210 217401005 SLC2515X 00643169680210 217418813 SLC2515X 00643169680210 217418906 SLC2515X 00643169680210 217427709 SLC2515X 00643169680210 217487819 SLC2515X 00643169680210 217498813 SLC2515X 00643169680210 217542636 SLC2515X 00643169680210 217602540 SLC2515X 00643169680210 217646866 SLC2515X 00643169680210 217693884 SLC2515X 00643169680210 217859788 SLC2515X 00643169680210 217905823 SLC2515X 00643169680210 218045287 SLC2520X 00643169680227 217271256 SLC2520X 00643169680227 217387129 SLC2520X 00643169680227 217404048 SLC2520X 00643169680227 217418909 SLC2520X 00643169680227 217434922 SLC2520X 00643169680227 217487821 SLC2520X 00643169680227 217498819 SLC2520X 00643169680227 217542632 SLC2520X 00643169680227 217646868 SLC2520X 00643169680227 217695009 SLC2520X 00643169680227 217859162 SLC2520X 00643169680227 217913794 SLC2525X 00643169680234 217218108 SLC2525X 00643169680234 217675585 SLC2530X 00643169680241 217246456 SLC2530X 00643169680241 217434923 SLC2530X 00643169680241 217498814 SLC2530X 00643169680241 217615649 SLC2530X 00643169680241 217704782 SLC2530X 00643169680241 217777613 SLC27512X 00643169680265 217427360 SLC27512X 00643169680265 217602535 SLC27512X 00643169680265 217695007 SLC27512X 00643169680265 217850362 SLC27515X 00643169680272 217542631 SLC27515X 00643169680272 217602534 SLC27515X 00643169680272 217646421 SLC27515X 00643169680272 217713071 SLC27515X 00643169680272 217799248 SLC27520X 00643169680289 217298668 SLC27520X 00643169680289 217387131 SLC27520X 00643169680289 217704783 SLC27520X 00643169680289 217832948 SLC3010X 00643169680319 217271255 SLC3010X 00643169680319 217693880 SLC3010X 00643169680319 217850363 SLC3012X 00643169680326 217306224 SLC3012X 00643169680326 217415821 SLC3012X 00643169680326 217498812 SLC3012X 00643169680326 217646869 SLC3012X 00643169680326 217704781 SLC3012X 00643169680326 217850360 SLC3015X 00643169680333 217246458 SLC3015X 00643169680333 217253579 SLC3015X 00643169680333 217306790 SLC3015X 00643169680333 217418910 SLC3015X 00643169680333 217498816 SLC3015X 00643169680333 217615646 SLC3015X 00643169680333 217693885 SLC3015X 00643169680333 217832949 SLC3015X 00643169680333 217913791 SLC3020X 00643169680340 217253571 SLC3020X 00643169680340 217297544 SLC3020X 00643169680340 217306222 SLC3020X 00643169680340 217401004 SLC3020X 00643169680340 217498818 SLC3020X 00643169680340 217646872 SLC3020X 00643169680340 217695008 SLC3020X 00643169680340 217859163 SLC3025X 00643169680357 217306221 SLC3025X 00643169680357 217487817 SLC3030X 00643169680364 217218124 SLC3030X 00643169680364 217427708 SLC3030X 00643169680364 217602537 SLC3030X 00643169680364 217850358 SLC3506X 00643169680401 217246454 SLC3506X 00643169680401 217713072 SLC3510X 00643169680418 217668583 SLC3512X 00643169680425 217913789 SLC3515X 00643169680432 217271252 SLC3515X 00643169680432 217415823 SLC3515X 00643169680432 217498817 SLC3515X 00643169680432 217668580 SLC3515X 00643169680432 217913788 SLC3520X 00643169680449 217646424 SLC3520X 00643169680449 217676626 SLC3520X 00643169680449 217832947 SLC3520X 00643169680449 217850361 SLC3530X 00643169680463 217940068 SLC4010X 00643169680517 217246459 SLC4012X 00643169680524 217668581 SLC4012X 00643169680524 217905819 SLC4015X 00643169680531 217498820 SLC4015X 00643169680531 217615648 SLC4015X 00643169680531 217859790 SLC4020X 00643169680548 217427353 SLC4020X 00643169680548 217487820 SLC4020X 00643169680548 217606585 SLC4025X 00643169680555 217823440 SLC4030X 00643169680562 217823444 
Recalling Firm/
Manufacturer		 Medtronic Vascular Galway DBA Medtronic Ireland
Parkmore Business Park West
Galway Ireland
For Additional Information Contact Wendy Dougherty
707-541-3004
Manufacturer Reason
for Recall		 Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
FDA Determined
Cause 2		 Under Investigation by firm
Action Medtronic notified it consignees by letter beginning on 09/03/2019. The firm requested the return of the affected product.
Quantity in Commerce 98675 units
Distribution worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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