Z-0661-2010

Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with...

Name: Z-0661-2010 Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with...
Creator: Thomas Medical Products Inc
Published: 2009-12-17
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2009-12-17 / Terminated / root cause: design

FDA source

Thomas Medical Products Inc began a recall of Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various... on 2009-12-17. The reason FDA records is "Radiopaque sheath tip may fracture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0661-2010
Status: Terminated
Initiated: 2009-12-17
Posted: 2010-02-02
Terminated: 2010-11-01
Recalling firm: Merit Medical Systems, Inc.
Product: 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.
Product code: DYB Introducer, Catheter
Reason for recall: Radiopaque sheath tip may fracture
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 60,982 units
Distribution: Nationwide.
Product codes and lots: 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 code DYB

K003731Class IISafesheath Msp Introducer Sheath Kit with Integral Hemostasis ValveThomas Medical Products, Inc. / cleared 2001-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)