Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 129 of 138
Terumo Cardiovascular Systems Corporation
Class II Terminated
Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula...
Reason: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae...
Z-1218-2014 March 26, 2014 Ann Arbor, MI
Boston Scientific Corporation
Class II Terminated
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Reason: The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed p...
Z-1164-2014 March 19, 2014 Maple Grove, MN
Biosense Webster, Inc.
Class II Terminated
PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-...
Reason: Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the re...
Z-1176-2014 March 19, 2014 Irwindale, CA
Medtronic Vascular
Class III Terminated
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monit...
Reason: Incorrect master label.
Z-1121-2014 March 5, 2014 Danvers, MA
Biosense Webster, Inc.
Class II Terminated
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAY...
Reason: Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particu...
Z-1045-2014 February 26, 2014 Irwindale, CA
Biocardia, Inc.
Class II Terminated
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intend...
Reason: Tyvek packaging may be worn, causing loss of package integrity.
Z-0991-2014 February 26, 2014 San Carlos, CA
B. Braun Medical, Inc.
Class II Terminated
SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter in...
Reason: Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The SAFSITE¿ Injection Site is inte...
Z-0987-2014 February 26, 2014 Allentown, PA
Boston Scientific Corporation
Class II Terminated
Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
Reason: Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatat...
Z-0969-2014 February 19, 2014 Maple Grove, MN
Boston Scientific Corporation
Class II Terminated
Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
Reason: Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatat...
Z-0971-2014 February 19, 2014 Maple Grove, MN
Edwards Lifesciences, LLC
Class II Terminated
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Reason: Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open ...
Z-0918-2014 February 12, 2014 Draper, UT
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve i...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Z-0864-2014 February 5, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device ...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Z-0860-2014 February 5, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Z-0862-2014 February 5, 2014 Raynham, MA
Boston Scientific Corporation
Class II Terminated
Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate wi...
Reason: Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.
Z-0900-2014 February 5, 2014 Fremont, CA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable de...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Z-0863-2014 February 5, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides con...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Z-0859-2014 February 5, 2014 Raynham, MA
Bard Access Systems
Class II Terminated
MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Ac...
Reason: Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr ...
Z-0814-2014 January 29, 2014 Salt Lake City, UT
Codman & Shurtleff, Inc.
Class I Terminated
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BC...
Reason: Incorrect instructions for use (IFU).
Z-0789-2014 January 29, 2014 Raynham, MA
Bard Access Systems
Class II Terminated
Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into vario...
Reason: Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr ...
Z-0815-2014 January 29, 2014 Salt Lake City, UT
Boston Scientific Corporation
Class II Terminated
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the...
Reason: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Z-0710-2014 January 22, 2014 Marlborough, MA
Boston Scientific Corporation
Class II Terminated
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
Reason: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Z-0712-2014 January 22, 2014 Marlborough, MA
Boston Scientific Corporation
Class II Terminated
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
Reason: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Z-0711-2014 January 22, 2014 Marlborough, MA
Merit Medical Systems, Inc.
Class II Terminated
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microc...
Reason: Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the f...
Z-0614-2014 January 8, 2014 South Jordan, UT
Integra LifeSciences Corp.
Class II Terminated
Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use...
Reason: Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed value...
Z-0602-2014 January 8, 2014 Plainsboro, NJ
B. Braun Medical, Inc.
Class II Terminated
B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or...
Reason: One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.
Z-0559-2014 January 1, 2014 Allentown, PA