Home / Recalls / Medtronic Perfusion Systems / Z-0786-2019

Z-0786-2019 Class II Ongoing

Recalled by Medtronic Perfusion Systems — Brooklyn Park, MN

FDA device recall Z-0786-2019 was initiated by Medtronic Perfusion Systems on Nov 27, 2018 and is designated Class II. Reason for recall: Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in… The recall status is ongoing. Affected quantity: 7587 units.

Recall Details

Product Type
Devices
Report Date
Feb 6, 2019
Initiation Date
Nov 27, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7587 units

Product Description

SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.

Reason for Recall

Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.

Distribution Pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden.

Code Information

BTC93: GTIN/UDI Lot/Serial Numbers 10673978522545 215691544 10673978522545 215691545 10673978522545 215737228 10673978522545 215737229 10673978522545 215782206 10673978522545 215782207 10673978522545 215816859 10673978522545 215816860 10673978522545 215857423 10673978522545 215857424 10673978522545 215903431 10673978522545 215946277 10673978522545 216245142 10673978522545 215875581 10673978522545 215875582 10673978522545 215875583 10673978522545 216045172 10673978522545 216062720 10673978522545 216107788 10673978522545 216150361 10673978522545 216199988 10673978522545 216238209 10673978522545 216245141 10673978522545 216372965 10673978522545 216372966 10673978522545 216372967 10673978522545 216421235 10673978522545 216421236 10673978522545 216438179 BTC98: GTIN/UDI Lot/Serial Numbers 10673978522576 215782205 10673978522576 215903430 10673978522576 216034160 10673978522576 216062718 10673978522576 216238210

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0786-2019
openFDA file date
Oct 21, 2026
Loaded by RegDataLab
Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources