Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Check against the official notice below — it lists the full affected range.
Medtronic Vascular Galway is recalling the Solarice Rapid Exchange Balloon Dilatation Catheter, a device used in coronary angioplasty procedures. The recall affects approximately 105,633 units distributed worldwide, including throughout the United States, Puerto Rico, and numerous international locations. The recall was initiated due to difficulties with stylette removal on both Euphora and Solarice products.
The affected devices are identified by specific product numbers and lot codes listed in the recall record, spanning multiple SLC model variants with lot numbers ranging from 212610378 through 212710910. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Stylette removal difficulties on the Euphora and Solarice products.
Reason for recall: Stylette removal difficulties on the Euphora and Solarice products. Distribution: Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ESTONIA, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, Quantity: 105,633 (OUS) Lot/code info: Product Number / CFN GTIN Lot SLC2525X 00643169680234 212610381 SLC3520X 00643169680449 212610395 SLC1520X 00643169680043 212610391 SLC2015X 00643169680081 212610384 SLC2020X 00643169680098 212621132 SLC2515X 00643169680210 212610388 SLC2520X 00643169680227 212621130 SLC4015X 00643169680531 212610378 SLC27520X 00643169680289 212621127 SLC27515X 00643169680272 212621128 SLC3515X 00643169680432 212621129 SLC3020X 00643169680340 212663250 SLC22510X 00643169680135 212671839 SLC3010X 00643169680319 212663249 SLC22506X 00643169680128 212671834 SLC2506X 00643169680180 212671836 SLC2025X 00643169680104 212671880 SLC37515X 00643169680487 212671833 SLC32515X 00643169680388 212671838 SLC4010X 00643169680517 212671837 SLC22520X 00643169680166 212663251 SLC3006X 00643169680302 212671835 SLC2020X 00643169680098 212691165 SLC2512X 00643169680203 212691118 SLC2515X 00643169680210 212691164 SLC2015X 00643169680081 212691160 SLC22512X 00643169680142 212691163 SLC2025X 00643169680104 212691167 SLC2020X 00643169680098 212702017 SLC2530X 00643169680241 212691173 SLC1512X 00643169680029 212691119 SLC2515X 00643169680210 212702018 SLC2015X 00643169680081 212702463 SLC2012X 00643169680074 212710905 SLC2030X 00643169680111 212710910 SLC2510X 00643169680197 212710908 SLC2512X 00643169680203 212702020 SLC2520X 00643169680227 212702019 SLC22520X 00643169680166 212702021 SLC2015X 00643169680081 212702016 SLC3030X 00643169680364 212691171 SLC2020X 00643169680098 212702465 SLC2012X 00643169680074 212709027
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.