Z-0168-2012

SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic...

Name: Z-0168-2012 SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic...
Creator: Thomas Medical Products Inc
Published: 2011-10-07
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2011-10-07 / Terminated / root cause: manufacturing process

FDA source

Thomas Medical Products Inc began a recall of SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery... on 2011-10-07. The reason FDA records is "Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0168-2012
Status: Terminated
Initiated: 2011-10-07
Posted: 2012-01-11
Terminated: 2012-08-29
Recalling firm: Merit Medical Systems, Inc.
Product: SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery System - Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2-09; CSG/WROLEY/L/BCor-1-09; CSG/Worley/R-1-09; CSGWORBC10M; CSGWORBC29M; CSGWORLBC19M; LVI/66-5.5-CR; LVI/66-5.5-RE; LVI/75-5-62-07-HO; LVI/75-5-62-07-HS; LVI/75-5-62-07-MP; LVI/75-5-62-07-RE; LVI/75-5-66-5.5-RE; LVI/Tele/B-60-07-HO; LVI/Tele/B-60-07-HS; LVI/Tele/B-60-07-MP; LVI/Tele/B-60-07-RE; RL065; RL066; RL067; and RL068 This device is intended to be used for the introduction of various types of pacing or defibrillator leads and catheters.
Product code: DYB Introducer, Catheter
Reason for recall: Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm,GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 7, 2011, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately segregate all affected product in a manner that ensures it will not be used; return any product with reference to the return authorization (RA) number or contact customer service representative to facilitate return of product; if any affected product has been forwarded to another facility, contact that facility to arrange return, and complete and return the attached product reconciliation form. If you have any questions, you may contact the Customer Service number at 1-866-446-3003 Monday through Friday from 8:30am to 5:00pm EDT.
Quantity in commerce: 33,134
Distribution: Nationwide distribution: CA only.
Product codes and lots: Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2-09; CSG/WROLEY/L/BCor-1-09; CSG/Worley/R-1-09; CSGWORBC10M; CSGWORBC29M; CSGWORLBC19M; LVI/66-5.5-CR; LVI/66-5.5-RE; LVI/75-5-62-07-HO; LVI/75-5-62-07-HS; LVI/75-5-62-07-MP; LVI/75-5-62-07-RE; LVI/75-5-66-5.5-RE; LVI/Tele/B-60-07-HO; LVI/Tele/B-60-07-HS; LVI/Tele/B-60-07-MP; LVI/Tele/B-60-07-RE; RL065; RL066; RL067; and RL068. Lot Numbers: S24064, S24120; S24129; S24359; S24618; S24683; S24838; S24932; S25222; S25489; S25540; S25544; S25772; S25937; S25945; S26333; S26420; S26460; S36539; S36540; S26560; S36759; S36861; S26881; S26987; S27221; S27222; S27275; S27288; S27370; S27477; S27478; S27947; S27971; S27985; S28023; S28172; S28306; S28339; S28401; S28632X1; S28791; S29083; S29878; S30060X1; S30262X1; S30332X1; S30333X1; S30622X1; S30630; S30739; S30852X1; S30889X1; S30901X1; S30913; S30919X1; S30956X1; S30970; S30986X1; S30997X1; S31005X1; S31045; S31076; S31080X1; S31081; S31097; S31098; S31142X1; S31212X1; S31215X1; S31245; S31306; S31316; S31327X1; S31331X1; S31334; S31340; S31341; S31439; S31507; S31533X1; S31534X1; S31535X1; S31563; S31650; S31674; S31709; S31771X1; S31779X1; S31917X1; S31962;S32102; S32139; S32156; S32167; S32178X1; S32219; S32222; S32238; S32263; S32282; S32308; S32327; S32506X1; S32543X1; S32565X1; S32566X1; S32568X1; S32602; S32605X1; S32610; S32675; S32684; S32699X1; S32714; S32715; S32716; S32717; S32737; S32765; S32796; S32831; S32882; S32957; S32994; S33026; S33065; S33067; S33076; S33084; S33129; S33149X1; S33161X1; S33236; S33238; S33301; S33322; S33324; S33398; S33399; S33403; S33412; S33478; S33543; S33544; S33614; S33649; S33687; S33758; S33889; S33921; S33939; S34026; S34082; S34096; S34342; S34375; S34485; S34689; S34690; S36110X1; and S36118X1.

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)