Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-1276-2015

Z-1276-2015 Class I Terminated

Recalled by Medtronic Inc. Cardiac Rhythm Disease Management — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
March 25, 2015
Initiation Date
February 23, 2015
Termination Date
October 7, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
151 (4 US, 147 OUS)

Product Description

Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.

Reason for Recall

Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.

Distribution Pattern

Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.

Code Information

Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419.

Other recalls by Medtronic Inc. Cardiac Rhythm Disease Management

  • Z-0022-2016 Class II — Medtronic Medical Device Identification Card for SureScan pacemaker patients. (September 15, 2015)
  • Z-2777-2015 Class II — Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing c (September 1, 2015)
  • Z-1365-2015 Class II — Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx onl (March 23, 2015)
  • Z-1356-2015 Class II — Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Us (March 17, 2015)
  • Z-1661-2014 Class II — Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generat (April 29, 2014)
  • Z-0995-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (January 30, 2014)
  • Z-0999-2014 Class II — Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB787 (January 30, 2014)
  • Z-0997-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vent (January 30, 2014)
  • Z-0996-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vent (January 30, 2014)
  • Z-0998-2014 Class II — Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 ( (January 30, 2014)