Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 72 of 138
Cook Inc.
Class I Terminated
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter...
Reason: Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in t...
Z-1758-2019 June 26, 2019 Bloomington, IN
Cook Inc.
Class I Terminated
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter i...
Reason: Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in t...
Z-1757-2019 June 26, 2019 Bloomington, IN
Becton Dickinson & Company
Class II Terminated
BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
Reason: Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
Z-1710-2019 June 12, 2019 Franklin Lakes, NJ
Cook Inc.
Class II Terminated
Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284
Reason: Affected products may have been manufactured with the catheter distal end hole too small
Z-1723-2019 June 12, 2019 Bloomington, IN
Cook Inc.
Class II Terminated
Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
Reason: Affected products may have been manufactured with the catheter distal end hole too small
Z-1724-2019 June 12, 2019 Bloomington, IN
Cook Inc.
Class II Terminated
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Reason: Affected products may have been manufactured with the catheter distal end hole too small
Z-1722-2019 June 12, 2019 Bloomington, IN
Cook Inc.
Class II Terminated
Thoracentesis Set, RPN C-THS-850, Order # G03286
Reason: Affected products may have been manufactured with the catheter distal end hole too small
Z-1725-2019 June 12, 2019 Bloomington, IN
Stryker Neurovascular
Class II Terminated
Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-111...
Reason: A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.
Z-1708-2019 June 12, 2019 Fremont, CA
Terumo Medical Corporation
Class I Terminated
SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product...
Reason: There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface...
Z-1374-2019 June 5, 2019 Elkton, MD
PENTAX of America Inc
Class II Terminated
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of gener...
Reason: Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the cont...
Z-1326-2019 May 22, 2019 Redwood City, CA
PENTAX of America Inc
Class II Terminated
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of g...
Reason: Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the cont...
Z-1325-2019 May 22, 2019 Redwood City, CA
PENTAX of America Inc
Class II Terminated
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field ...
Reason: Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the cont...
Z-1327-2019 May 22, 2019 Redwood City, CA
Edwards Lifesciences, LLC
Class I Terminated
Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openi...
Reason: Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Z-1117-2019 May 1, 2019 Irvine, CA
Edwards Lifesciences, LLC
Class I Terminated
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial ...
Reason: Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Z-1116-2019 May 1, 2019 Irvine, CA
Smiths Medical ASD Inc.
Class II Terminated
Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radio...
Reason: Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in t...
Z-1218-2019 May 1, 2019 Minneapolis, MN
GETINGE US SALES LLC
Class III Terminated
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode ...
Reason: Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
Z-1221-2019 May 1, 2019 WAYNE, NJ
Medical Components, Inc dba MedComp
Class II Terminated
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Reason: Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Z-1149-2019 April 24, 2019 Harleysville, PA
Cordis Corporation
Class III Terminated
Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or ...
Reason: Frayed pieces of the mounting card being inside the primary packaging.
Z-1198-2019 April 24, 2019 Miami Lakes, FL
Arrow International Inc
Class II Terminated
Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
Reason: The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
Z-1119-2019 April 17, 2019 Reading, PA
Edwards Lifesciences, LLC
Class II Ongoing
Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the...
Reason: Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.
Z-1100-2019 April 17, 2019 Irvine, CA
Arrow International Inc
Class II Terminated
Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
Reason: The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
Z-1118-2019 April 17, 2019 Reading, PA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class III Ongoing
Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal a...
Reason: The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Z-1069-2019 April 3, 2019 Mounds View, MN
ConvaTec, Inc
Class II Ongoing
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an...
Reason: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Z-1037-2019 March 27, 2019 Greensboro, NC
PENTAX of America Inc
Class II Terminated
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifi...
Reason: The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the ...
Z-0970-2019 March 13, 2019 Redwood City, CA
Cook Inc.
Class II Terminated
Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of ...
Reason: There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
Z-0967-2019 March 6, 2019 Bloomington, IN