Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 109 of 138
Cook Inc.
Class II Terminated
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
Reason: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a dev...
Z-2610-2016 August 31, 2016 Bloomington, IN
Reshape Medical Inc
Class II Terminated
ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with d...
Reason: Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the result of an assembly...
Z-2552-2016 August 24, 2016 San Clemente, CA
Medtronic Cardiovascular Surgery-the Heart Valve Division
Class II Terminated
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery...
Reason: Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
Z-2546-2016 August 24, 2016 Santa Ana, CA
AccessClosure, Inc., A Cardinal Health Company
Class II Terminated
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sit...
Reason: A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
Z-2329-2016 August 10, 2016 Santa Clara, CA
WalkMed Infusion, LLC
Class II Terminated
T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needl...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2230-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a pati...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2225-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter i...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2227-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needl...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2224-2016 July 27, 2016 Englewood, CO
Stryker Sustainability Solutions
Class I Terminated
AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
Reason: Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.
Z-2096-2016 July 27, 2016 Tempe, AZ
WalkMed Infusion, LLC
Class II Terminated
T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container t...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2235-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient throu...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2226-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or cathet...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2233-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2229-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a conta...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2231-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter ins...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2228-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted i...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2221-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or cathet...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2222-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or ...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2234-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or cathe...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2232-2016 July 27, 2016 Englewood, CO
WalkMed Infusion, LLC
Class II Terminated
T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted...
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Z-2223-2016 July 27, 2016 Englewood, CO
Arrow International Inc
Class II Terminated
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterizat...
Reason: Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
Z-2201-2016 July 20, 2016 Reading, PA
Arrow International Inc
Class II Terminated
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterizat...
Reason: Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
Z-2202-2016 July 20, 2016 Reading, PA
Sorin Group USA, Inc.
Class II Terminated
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit dur...
Reason: Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle ...
Z-2147-2016 July 20, 2016 Arvada, CO
Hummingbird Med
Class I Terminated
ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
Reason: Hummingbird Med Devices, Inc. is recalling the Hummi Micro Draw because of insertion difficulties.
Z-1908-2016 July 13, 2016 Lake Forest, CA
Arrow International Inc
Class II Terminated
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or...
Reason: Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
Z-2136-2016 July 13, 2016 Reading, PA