Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 127 of 138
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured b...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1818-2014 July 2, 2014 Fremont, CA
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; ...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1816-2014 July 2, 2014 Fremont, CA
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 260 CM Length Manufactured for Covidien, Plymouth, MN; Manufactur...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1817-2014 July 2, 2014 Fremont, CA
SteriGear, LLC
Class II Terminated
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage C...
Reason: SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.
Z-1848-2014 July 2, 2014 Provo, UT
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufacture...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1823-2014 July 2, 2014 Fremont, CA
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactur...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1815-2014 July 2, 2014 Fremont, CA
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1812-2014 July 2, 2014 Fremont, CA
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydroph...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1822-2014 July 2, 2014 Fremont, CA
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufacture...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1813-2014 July 2, 2014 Fremont, CA
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1819-2014 July 2, 2014 Fremont, CA
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured ...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1814-2014 July 2, 2014 Fremont, CA
Nitinol Devices and Components, Inc.
Class I Terminated
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured...
Reason: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Z-1821-2014 July 2, 2014 Fremont, CA
Boston Scientific Corporation
Class II Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for c...
Reason: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Z-1798-2014 June 25, 2014 Fremont, CA
Boston Scientific Corporation
Class II Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters fo...
Reason: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Z-1794-2014 June 25, 2014 Fremont, CA
Boston Scientific Corporation
Class II Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for ...
Reason: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Z-1795-2014 June 25, 2014 Fremont, CA
Boston Scientific Corporation
Class II Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters fo...
Reason: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Z-1797-2014 June 25, 2014 Fremont, CA
Boston Scientific Corporation
Class II Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters ...
Reason: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Z-1799-2014 June 25, 2014 Fremont, CA
Boston Scientific Corporation
Class II Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters...
Reason: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Z-1796-2014 June 25, 2014 Fremont, CA
BioDerm, Inc.
Class II Terminated
BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an ext...
Reason: On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Cl...
Z-1744-2014 June 18, 2014 Largo, FL
CooperSurgical, Inc.
Class II Terminated
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Reason: Sterility of the device may be compromised due to unsealed pouch
Z-1782-2014 June 18, 2014 Trumbull, CT
Teleflex Medical
Class II Terminated
Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystec...
Reason: Several complaints were received for the metal support tube missing from the cholangiogram catheter.
Z-1786-2014 June 18, 2014 Durham, NC
Teleflex Medical
Class II Terminated
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fl...
Reason: Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
Z-1732-2014 June 18, 2014 Research Triangle Park, NC
BioDerm, Inc.
Class II Terminated
BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin pro...
Reason: On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male...
Z-1742-2014 June 18, 2014 Largo, FL
Cordis Corporation
Class II Terminated
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Reason: Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Z-1784-2014 June 18, 2014 Miami Lakes, FL
BioDerm, Inc.
Class II Terminated
BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for app...
Reason: On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male...
Z-1743-2014 June 18, 2014 Largo, FL