Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 128 of 138
Aesculap, Inc.
Class II Terminated
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into t...
Reason: AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
Z-1676-2014 June 11, 2014 Center Valley, PA
Medtronic Neuromodulation
Class II Terminated
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the i...
Reason: Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Z-1723-2014 June 11, 2014 Minneapolis, MN
Arrow International Inc
Class II Terminated
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
Reason: The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contain...
Z-1633-2014 May 28, 2014 Reading, PA
Greatbatch Medical
Class II Terminated
Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR B...
Reason: Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.
Z-1614-2014 May 21, 2014 Minneapolis, MN
InterValve Inc
Class II Terminated
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Reason: Leak issues were discovered through accelerated age testing.
Z-1621-2014 May 21, 2014 Minnetonka, MN
Medtronic Neuromodulation
Class II Terminated
Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers ...
Reason: This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening ov...
Z-1570-2014 May 14, 2014 Minneapolis, MN
Ev3, Inc.
Class II Terminated
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Periphera...
Reason: Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the deliv...
Z-1489-2014 April 30, 2014 Plymouth, MN
Arrow International Inc
Class II Terminated
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
Reason: Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit conta...
Z-1507-2014 April 30, 2014 Reading, PA
Arrow International Inc
Class II Terminated
Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.
Reason: Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.
Z-1494-2014 April 30, 2014 Reading, PA
Codman & Shurtleff, Inc.
Class II Terminated
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Uniti...
Reason: Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valve...
Z-1468-2014 April 23, 2014 Raynham, MA
Biocardia, Inc.
Class II Terminated
Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway throug...
Reason: Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
Z-1301-2014 April 2, 2014 San Carlos, CA
Trivascular, Inc
Class II Terminated
Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular ...
Reason: Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.
Z-1297-2014 April 2, 2014 Santa Rosa, CA
Biocardia, Inc.
Class II Terminated
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway thr...
Reason: Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
Z-1302-2014 April 2, 2014 San Carlos, CA
Convatec Inc.
Class II Terminated
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated late...
Reason: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Z-1238-2014 March 26, 2014 Skillman, NJ
Terumo Cardiovascular Systems Corporation
Class II Terminated
Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula a...
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-1220-2014 March 26, 2014 Ann Arbor, MI
Convatec Inc.
Class II Terminated
SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube whi...
Reason: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Z-1241-2014 March 26, 2014 Skillman, NJ
Terumo Cardiovascular Systems Corporation
Class II Terminated
Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous ...
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-1222-2014 March 26, 2014 Ann Arbor, MI
Terumo Cardiovascular Systems Corporation
Class II Terminated
Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube ven...
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-1224-2014 March 26, 2014 Ann Arbor, MI
Terumo Cardiovascular Systems Corporation
Class II Terminated
Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula a...
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-1221-2014 March 26, 2014 Ann Arbor, MI
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, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venou...
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-1219-2014 March 26, 2014 Ann Arbor, MI
Terumo Cardiovascular Systems Corporation
Class II Terminated
Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube ven...
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-1223-2014 March 26, 2014 Ann Arbor, MI
Convatec Inc.
Class II Terminated
Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coa...
Reason: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Z-1237-2014 March 26, 2014 Skillman, NJ
Convatec Inc.
Class II Terminated
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube ...
Reason: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Z-1240-2014 March 26, 2014 Skillman, NJ
Convatec Inc.
Class II Terminated
JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one ma...
Reason: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Z-1239-2014 March 26, 2014 Skillman, NJ
Convatec Inc.
Class II Terminated
Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricou...
Reason: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Z-1236-2014 March 26, 2014 Skillman, NJ