Recall Z-1365-2015— Medtronic Inc. Cardiac Rhythm Disease Management

Name: FDA recall Z-1365-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-23

Class II · Terminated

Class II FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2015-03-23, terminated 2016-08-11. It names 2 FDA 510(k) clearances: K130904, K071664. Product: Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.. Reason: Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material. A breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch..

Recalling firm: Medtronic Inc. Cardiac Rhythm Disease Management
Classification: Class II
Status: Terminated
Initiated: 2015-03-23
Terminated: 2016-08-11
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K130904 — TRELLIS-8 PERIPHERAL INFUSION SYSTEMCovidien·cleared 2013-10-25
K071664 — TRELLIS-6 PERIPHERAL INFUSION SYSTEMBacchus Vascular, Inc.·cleared 2007-07-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Reason for recall

Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material. A breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch.

Data sourced from openFDA. This site is unofficial and independent of the FDA.