Devices

SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer

Model / Serial
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 Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution: CA only.
Product Description
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.
Manufacturer
Thomas Medical Products Inc
1 Event
- Recall of SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer

Manufacturer

Thomas Medical Products Inc

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

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