BEUDAMED
    FDA Enforcement Class I Terminated

    Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483

    Recall: Z-1846-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1846-2020
    Event ID
    85057
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Applied Medical Resources Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2020
    Initiation Date
    October 24, 2019
    Classification Date
    May 7, 2020
    Termination Date
    June 1, 2023
    Address
    22872 Avenida Empresa, N/A, Rancho Santa Margarita, CA, 92688-2650, United States

    Description

    Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483

    Reason

    The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.

    Code Info

    Model A4E01, PYTHON 5MM-40CM, lot numbers 1259463, 1268371, 1274343, 1281314, 1288397, 1291497, 1302766, 1305919, 1312958, 1317578, 1319209, 1324383, 1326383, 1333050, 1338309, 1339544. Model A4E02, PYTHON 5MM-80CM, lot numbers 1257416, 1268372, 1281315, 1283401, 1293028, 1294897, 1303013, 1305920, 1317579, 1319807, 1324384, 1331435, 1332003, 1338732, 1339490 Model A4E03, PYTHON 9MM-40CM, lot numbers 1256874,1263093,1269005,1276315,1281787,1287079,1298430,1303017, 1308139, 1319211, 1330447, 1331896, 1333407, 1337644, 1341362 (note: lot numbers edited for correctness 4/23/2021) Model A4E04, PYTHON 9MM-80CM, lot numbers 1255539, 1262756, 1269004, 1276316, 1281786, 1288847, 1293169, 1299257, 1303808, 1312595, 1319212, 1321387, 1325381, 1331884, 1332592, 1337686, 1339491 Model A4E05, PYTHON 11MM-40CM, lot numbers 1263092, 1268170, 1273184, 1278603, 1283650, 1288347, 1292823, 1296020, 1299013, 1305922, 1310451, 1318835, 1320036, 1323535, 1325777, 1330446, 1331328, 1337641, 1339492 Model A4E06, PYTHON 11MM-80CM, lot numbers 1261855, 1268451, 1276317, 1284924, 1290454, 1298079, 1305921, 1310623, 1320183, 1323280, 1330449, 1332579, 1337652, 1339493 Model A4E08, PYTHON 13MM-80CM, lot numbers 1252636, 1259464, 1263484, 1265630, 1266989, 1267854, 1268688, 1276314, 1281784, 1283399, 1287076, 1290936, 1294898, 1303211, 1306288, 1308127, 1312957, 1315919, 1317577, 1319637, 1320236, 1324382, 1332433, 1335657, 1339494 Model A4E09, PYTHON 14MM-80CM, lot numbers 1260019, 1273374, 1281783, 1283770, 1295466, 1299012, 1305368, 1317203, 1317876, 1319210, 1324390, 1330448, 1332593, 1337653, 1339495

    Distribution

    Worldwide distribution - United States: Nationwide OUS: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, United Kingdom

    Quantity

    28,799 catheters in total