Percutaneous Introducer System

• 15 recalls, same reason

  • Terminated Z-1462-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1461-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1520-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1464-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1466-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1467-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1521-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1470-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1463-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1522-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1465-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1471-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1519-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1468-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219
  • Terminated Z-1469-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K961219

  The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

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

1. 22 Jul 2005 Recall initiated FDA recalls Z-1467-05
2. 22 Jul 2005 Recall initiated FDA recalls Z-1521-05
3. 22 Jul 2005 Recall initiated FDA recalls Z-1470-05
4. 22 Jul 2005 Recall initiated FDA recalls Z-1463-05
5. 22 Jul 2005 Recall initiated FDA recalls Z-1522-05
6. 22 Jul 2005 Recall initiated FDA recalls Z-1465-05
7. 22 Jul 2005 Recall initiated FDA recalls Z-1471-05
8. 22 Jul 2005 Recall initiated FDA recalls Z-1519-05
9. 22 Jul 2005 Recall initiated FDA recalls Z-1468-05
10. 22 Jul 2005 Recall initiated FDA recalls Z-1469-05

6 earlier events are in the sections above.

510(k) Number

K961219 ↗

FDA product code

GEH

FDA applicant

Boston Scientific Corp

Device class

Class II

Regulation

21 CFR Part 878.4350

Advisory committee

General, Plastic Surgery

FDA decision

SESE Substantially Equivalent

Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).

• Erbe 20402-501 by Erbe Elektromedizin GmbH
• WA1000 by Wallach Surgical Devices, Inc.
• CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 by Cryomedical Sciences, Inc.
• cryoFORM cryoICE cryoablation probe by ATRICURE, INC.
• CMS URETHRAL WARMER by Cryomedical Sciences, Inc.
• MYOSCIENCE CRYO-TOUCH by Myoscience, Inc.
• CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 by GALIL MEDICAL LTD
• truFreeze System by CSA Medical
• CRYO-MONO CRYOGRNIC SYSTEM by Influence, Inc.
• VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM by Cryosurg, Inc.

• OPAL HDx™ M004OPAL14010

  Class II

  GUDID on market

• Acuity™

  Class III

  CE/MDD

• WALLSTENT-Uni™

  Class IIb

  CE/MDD

• Multi-Point Thermal Sensor

  Class IIa

  CE/MDR

See all devices from Boston Scientific →