Percutaneous Draining Catheter

• • Terminated Z-1099-2018 FDA Class II ·initiated 12 Dec 2017

  Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.

• 4 recalls, same reason

  • Terminated Z-1334-2009 FDA Unclassified (pre-2012) ·initiated 18 Mar 2009
  • Terminated Z-1338-2009 FDA Unclassified (pre-2012) ·initiated 18 Mar 2009 ·on shared 510(k) K811378
  • Terminated Z-1335-2009 FDA Unclassified (pre-2012) ·initiated 18 Mar 2009 ·on shared 510(k) K811378
  • Terminated Z-1336-2009 FDA Unclassified (pre-2012) ·initiated 18 Mar 2009 ·on shared 510(k) K811378

  Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.

• • Terminated Z-1499-06 FDA Unclassified (pre-2012) ·initiated 10 Aug 2006

  Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.

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

510(k) Number

K811378 ↗

FDA Product Code

GBW

Device Class

Class I

Regulation

21 CFR Part 878.4200

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Hypodermic Needles & Syringes

  Class I

  FDA 510(k) K821348 Active Cleared 10 Jun 1982

• Medi-Tech Dilatation Catheters

  Class II

  FDA 510(k) K843383 Active Cleared 24 Oct 1984

• Catheter, External Male Nursing Care

  Class II

  FDA 510(k) K781780 Active Cleared 7 Dec 1978

• Catheter, Transluminal Balloon

  Class I

  FDA 510(k) K781772 Active Cleared 6 Mar 1979

• Enter-A1 Enteric Feeding Tube

  Class II

  FDA 510(k) K812279 Active Cleared 25 Aug 1981

• Coagulation Reference Plasma, Abnormal

  Class II

  FDA 510(k) K904073 Active Cleared 22 Oct 1990

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