Events

Recall of Device Recall Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thomas Medical Products Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54193
  • Event Risk Class
    Class 1
  • Event Number
    Z-0661-2010
  • Event Initiated Date
    2009-12-17
  • Event Date Posted
    2010-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87803
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    vascular introducer - Product Code DYB
  • Reason
    Radiopaque sheath tip may fracture.
  • Action
    GE Healthcare Thomas Medical Products firm issued an Urgent Medical Device Correction email on 12/23/09 to the distributor to discontinue distribution and return any affected products. The distributor was instructed to conduct a sub recall regarding the issue. Press issued 1/29/2010.

Device

Device Recall Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with ...
  • Model / Serial
    Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09, CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M, CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07, CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09. Lot numbers: S16716, S17215, S17216, S17248, S17349, S17447, S17448, S17449, S17478, S17596, S17640, S17675, S17789, S17790, S17795, S17864, S18000, S18004, S18290, S18291, S18336, S18337, S18352, S18529, S18535, S18593, S18670, S18725, S18736, S18744, S18745, S18861, S18862, S18952, S18962, S18974, S19051, S19060, S19135, S19153, S19161, S19173, S19174, S19175, S19196, S19262, S19264, S19290, S19291, S19292, S19409, S19428, S19450, S19564, S19742, S19743, S19756, S19757, S19906, S19959, S19961, S19966, S19991, S20007, S20019, S20101, S20154, S20170, S20297, S20298, S20331, S20491, S20494, S20505, S20704, S20713, S20848, S21002, S21071, S21115, S21128, S21236, S21557, S21650, S21651, S21652, S21695, S22085, S22160, S22216, S22228, S22229, S22244, S22282, S22302, S22367, S22368, S22371, S22396, S22397, S22491, S22675, S22676, S22746, S23020, S23021, S23022, S23052, S23092, S23103, S23111, S23112, S23225, S23384, S23387, S23388, S23402, S23403, S23492, S23507, S23508, S23543, S23618, S23795, S23926, S23927, S23956, S24026, S24027, S24101, S24174, S24175, S24341, S24353, S24354, S24355, S24619, S24620, S24772, S24800, S24852, S24906, S24907, S24931, S24951, S24956, S24958, S24978, S25050, S25051, S25052, S25082, S25097, S25121, S25140, S25141, S25142, S25239, S25241, S25323, S25324, S25353, S25404, S25433, S25469, S25486, S25487, S25494, S25497, S25590, S25590X1, S25594, S25720, S25721, S25806, S25807, S25896, S26039, S26039X1, S26040, S26040X1, S26088, S26095, S26183, S26183X1, S26345, S26554X1, S26570X1, S26576, S26635X1, S26636X1, S26637X1, S26752, S26754, S26833, S26834, S26912, S27030, S23031, S27032, S27056, S27057, S27186, S27242, S27321, S27504, S27610, S27611, S27617, S27646, S27670, S27876, S27895, S27913, S27914, S27924, S27952, S28054, S28214, S28215, S28232, S28272, S28273, S28283, S28326, S28360, S28391, S28460, S28485, S28564, S28576, S28731, S28808, S28894, S28939, S29270, S29492, S29669, S29736, S29766, S29767, S29813, S29823, S29879, S30059, S20357, S30060, S30258, S99009X1, S99010X1, S99011X1, and S99052X1.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and catheters. The product is shipped 5 per carton. Product is distributed by Pressure Products. Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09, CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M, CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07, CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09.
  • Manufacturer
    Thomas Medical Products Inc

Manufacturer

Thomas Medical Products Inc
  • Manufacturer Address
    Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
  • Source
    USFDA