Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 41 of 138
Medtronic Vascular
Class II Terminated
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Reason: Sterility may be compromised due to an unsealed pouch
Z-1245-2021 March 17, 2021 Danvers, MA
Medtronic Vascular
Class II Terminated
Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
Reason: Sterility may be compromised due to an unsealed pouch
Z-1246-2021 March 17, 2021 Danvers, MA
Medtronic Vascular
Class II Terminated
Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
Reason: Sterility may be compromised due to an unsealed pouch
Z-1248-2021 March 17, 2021 Danvers, MA
Medical Components, Inc dba MedComp
Class II Ongoing
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Reason: The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to ...
Z-1184-2021 March 17, 2021 Harleysville, PA
Medtronic Vascular
Class II Terminated
Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Reason: Sterility may be compromised due to an unsealed pouch
Z-1247-2021 March 17, 2021 Danvers, MA
Acist Medical Systems
Class I Terminated
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound exami...
Reason: Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-...
Z-1161-2021 March 10, 2021 Eden Prairie, MN
Siemens Medical Solutions USA, Inc
Class II Terminated
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies...
Reason: System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
Z-1173-2021 March 10, 2021 Malvern, PA
Aomori Olympus Co., Ltd.
Class II Terminated
B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Reason: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Z-0961-2021 February 17, 2021 Kuroishi, N/A
ICU Medical, Inc.
Class II Terminated
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, no...
Reason: Due to the incorrect filter assembly.
Z-0956-2021 February 17, 2021 San Clemente, CA
Aomori Olympus Co., Ltd.
Class II Terminated
B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Reason: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Z-0963-2021 February 17, 2021 Kuroishi, N/A
Aomori Olympus Co., Ltd.
Class II Terminated
B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
Reason: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Z-0965-2021 February 17, 2021 Kuroishi, N/A
Argon Medical Devices, Inc
Class II Terminated
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Cat...
Reason: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could res...
Z-1072-2021 February 17, 2021 Athens, TX
ICU Medical, Inc.
Class II Terminated
60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for th...
Reason: Due to the incorrect filter assembly.
Z-0955-2021 February 17, 2021 San Clemente, CA
Aomori Olympus Co., Ltd.
Class II Terminated
B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Reason: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Z-0962-2021 February 17, 2021 Kuroishi, N/A
Argon Medical Devices, Inc
Class II Terminated
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight ca...
Reason: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could res...
Z-1075-2021 February 17, 2021 Athens, TX
Arrow International Inc
Class II Terminated
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
Reason: The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-...
Z-1106-2021 February 17, 2021 Reading, PA
Prytime Medical Devices, Inc.
Class II Terminated
PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE...
Reason: There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guid...
Z-0959-2021 February 17, 2021 Boerne, TX
Argon Medical Devices, Inc
Class II Terminated
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight ca...
Reason: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could res...
Z-1076-2021 February 17, 2021 Athens, TX
Argon Medical Devices, Inc
Class II Terminated
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter,...
Reason: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could res...
Z-1073-2021 February 17, 2021 Athens, TX
Baxter Healthcare Corporation
Class II Terminated
Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient u...
Reason: There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
Z-1102-2021 February 17, 2021 Deerfield, IL
ICU Medical, Inc.
Class II Terminated
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the adminis...
Reason: Due to the incorrect filter assembly.
Z-0958-2021 February 17, 2021 San Clemente, CA
Aomori Olympus Co., Ltd.
Class II Terminated
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
Reason: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Z-0964-2021 February 17, 2021 Kuroishi, N/A
ICU Medical, Inc.
Class II Terminated
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the...
Reason: Due to the incorrect filter assembly.
Z-0957-2021 February 17, 2021 San Clemente, CA
Braxton Medical Corporation
Class II Ongoing
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and ...
Reason: Recalled products do not have FDA approval for sale in the United States.
Z-0930-2021 February 3, 2021 Lutz, FL
Stryker Sustainability Solutions
Class II Terminated
Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
Reason: A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual sh...
Z-2113-2020 February 3, 2021 Tempe, AZ