Trellis-6 Peripheral Infusion System

• • Terminated Z-1365-2015 FDA Class II ·initiated 23 Mar 2015 ·on shared 510(k) K071664

  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.

• • Terminated Z-1017-2015 FDA Class I ·initiated 10 Dec 2014 ·on shared 510(k) K071664

  A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labeled as distal.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K071664 ↗

FDA Product Code

QEY

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Trellis Infusion System (10cm Infusion Length); Trellis Infusion System (20cm Infusion Length)

  Class II

  FDA 510(k) K013635 Active Cleared 11 Feb 2002

• TRELLIS-6 Peripheral Infusion System (140CM Catheter Length, 10CM Infusion Length)

  Class II

  FDA 510(k) K023514 Active Cleared 2 Dec 2002

• Bacchus Thrombectomy Catheter (Btc), Model Btc-0755

  Class II

  FDA 510(k) K003570 Active Cleared 6 Jun 2001

• Trellis Reserve Infusion System

  Class II

  FDA 510(k) K032261 Active Cleared 22 Aug 2003

• Trellis Plus Infusion System (140cm Catheter Length 10cm Infusion Length 20cm (100cm Catheter Length 10cm Infusion H

  Class II

  FDA 510(k) K021958 Active Cleared 3 Jul 2002

• Solera Magnum Thrombectomy Catheter, 55 Cm, Model Bac Smg 007 055 & Solera Magnum Thrombectomy Catheter, 110 Cm

  Class II

  FDA 510(k) K022640 Active Cleared 2 Dec 2002

See all devices from Bacchus Vascular, Inc. →