Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 97 of 138
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transsepta...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0807-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the ...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0811-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the ...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0813-2017 December 28, 2016 Palm Harbor, FL
Smiths Medical ASD Inc.
Class II Terminated
Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all...
Reason: Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves.
Z-0789-2017 December 28, 2016 Minneapolis, MN
Oscor, Inc.
Class II Terminated
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the l...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0819-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punc...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0796-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0793-2017 December 28, 2016 Palm Harbor, FL
Teleflex Medical
Class II Terminated
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Reason: Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
Z-0771-2017 December 28, 2016 Research Triangle Park, NC
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal ...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0806-2017 December 28, 2016 Palm Harbor, FL
Angiodynamics, Inc.
Class II Terminated
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stif...
Reason: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the poten...
Z-0777-2017 December 28, 2016 Queensbury, NY
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal pu...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0800-2017 December 28, 2016 Palm Harbor, FL
Angiodynamics, Inc.
Class III Terminated
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened ...
Reason: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the poten...
Z-0772-2017 December 28, 2016 Queensbury, NY
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal pu...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0805-2017 December 28, 2016 Palm Harbor, FL
Angiodynamics, Inc.
Class III Terminated
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened M...
Reason: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the poten...
Z-0774-2017 December 28, 2016 Queensbury, NY
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal pun...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0791-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal ...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0802-2017 December 28, 2016 Palm Harbor, FL
Angiodynamics, Inc.
Class III Terminated
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffen...
Reason: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the poten...
Z-0776-2017 December 28, 2016 Queensbury, NY
Oscor, Inc.
Class II Terminated
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0815-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0817-2017 December 28, 2016 Palm Harbor, FL
Angiodynamics, Inc.
Class III Terminated
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened M...
Reason: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the poten...
Z-0773-2017 December 28, 2016 Queensbury, NY
Angiodynamics, Inc.
Class III Terminated
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened ...
Reason: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the poten...
Z-0775-2017 December 28, 2016 Queensbury, NY
Oscor, Inc.
Class II Terminated
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including th...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0812-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal pun...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0794-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0797-2017 December 28, 2016 Palm Harbor, FL
C.R. Bard, Inc.
Class II Terminated
BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It ...
Reason: Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Z-0736-2017 December 21, 2016 Covington, GA