Abbott Laboratories Inc. (St Jude Medical): Medical Device Recall in 2019 - (Recall #: Z-1493-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)

Product Classification:

Class II

Date Initiated: April 5, 2019

Date Posted: June 5, 2019

Recall Number: Z-1493-2019

Event ID: 82727

Reason for Recall:

In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may lead to intermittent contact force data to be displayed during the procedure.

Status: Terminated

Product Quantity: 317 units

Code Information:

UDI: 07640157990194 Serial Numbers: 33019, 33059, 33350, 33354, 33357, 33360, 33361, 33363, 33390, 33392, 33393, 33405, 33417, 33421, 33444, 33449, 33451, 33457, 33458, 33461, 33491, 33492, 33509, 33013, 33015, 33020, 33040, 33075, 33091, 33097, 33160, 33197, 33384, 33385, 33387, 33389, 33414, 33433, 33388, 33435, 33481, 33154, 33157, 33162, 33163, 33278, 33092, 33159, 33437, 33412, 33014, 33027, 33028, 33029, 33038, 33049, 33057, 33082, 33096, 33192, 33222, 33268, 33379, 33383, 33397, 33398, 33399, 33400, 33422, 33423, 33478, 33320, 33352, 33395, 33351, 33069, 33381, 33455, 33064, 33093, 33313, 33337, 33161, 33426, 33083, 33321, 33420, 33051, 33155, 33196, 33256, 33353, 33460, 33217, 33427, 33073, 33150, 33076, 33148, 33434, 33396, 33050, 33333, 33333, 33336, 33336, 33095, 33143, 33143, 33112, 33113, 33266, 33267, 33269, 33270, 33271, 33272, 33273, 33274, 33275, 33276, 33283, 33287, 33288, 33291, 33325, 33356, 33359, 33362, 33404, 33459, 33016, 33098, 33099, 33100, 33101, 33102, 33103, 33104, 33105, 33106, 33107, 33108, 33110, 33111, 33127, 33130, 33131, 33265, 33018, 33024, 33025, 33087, 33152, 33156, 33220, 33230, 33231, 33254, 33279, 33281, 33315, 33416, 33428, 33438, 33439, 33442, 33443, 33463, 33330, 33386, 33228, 33033, 33048, 33149, 33259, 33282, 33464, 33022, 33031, 33035, 33037, 33044, 33045, 33046, 33055, 33066, 33067, 33068, 33078, 33080, 33085, 33086, 33088, 33094, 33129, 33137, 33138, 33140, 33144, 33158, 33195, 33218, 33221, 33229, 33253, 33257, 33262, 33280, 33289, 33293, 33326, 33328, 33355, 33364, 33382, 33403, 33406, 33408, 33409, 33411, 33424, 33431, 33440, 33445, 33446, 33448, 33450, 33454, 33462, 33465, 33466, 33169, 33011, 33012, 33021, 33023, 33034, 33054, 33056, 33074, 33079, 33089, 33090, 33109, 33191, 33193, 33194, 33215, 33224, 33314, 33316, 33327, 33329, 33358, 33375, 33376, 33407, 33415, 33419, 33429, 33447, 33219, 33258, 33292, 33334, 33335, 33032, 33410, 33081, 33170, 33171, 33172, 33173, 33198, 33199, 33201, 33203, 33204, 33205, 33206, 33207, 33208, 33209, 33210, 33211, 33212, 33213, 33214, 33294, 33295, 33296, 33298, 33299, 33300, 33301, 33302, 33303, 33304, 33365, 33366, 33367, 33368, 33369, 33370, 33371, 33372, 33373, 33374, 33549, 33550, 33551, 33168, 33165, 33216, 33042, 33456, 33070, 33432, 33480, 33047, 33072, 33077, 33136, 33226, 33263, 33377, 33378,

Distribution Pattern:

US, UNITED KINGDOM, UAE, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDIA ARABIA, RUSSIA, ROMANIA, PORTUGAL, POLAND, PALESTINE, OMAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, LEBANON, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAN, GREECE, GERMANY, FRANCE, EL SALVADOR, EGYPT, DENMARK, Czech Republic, CHINA, CANADA, BULGARIA, BELGIUM, AUSTRIA, AUSTRALIA

Voluntary or Mandated:

Voluntary: Firm initiated