Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 114 of 138
Covidien LLC
Class II Terminated
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chroni...
Reason: Incorrectly packaged with a 90 degree bend at the distal tip
Z-0332-2016 December 2, 2015 North Haven, CT
Civco Medical Instruments Co. Inc.
Class II Terminated
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Reason: Sterility of the product cannot be assured.
Z-0290-2016 November 25, 2015 Kalona, IA
Civco Medical Instruments Co. Inc.
Class II Terminated
CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided ...
Reason: Sterility of the product cannot be assured.
Z-0286-2016 November 25, 2015 Kalona, IA
Civco Medical Instruments Co. Inc.
Class II Terminated
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044,...
Reason: Sterility of the product cannot be assured.
Z-0287-2016 November 25, 2015 Kalona, IA
Civco Medical Instruments Co. Inc.
Class II Terminated
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Gui...
Reason: Sterility of the product cannot be assured.
Z-0289-2016 November 25, 2015 Kalona, IA
Civco Medical Instruments Co. Inc.
Class II Terminated
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 6...
Reason: Sterility of the product cannot be assured.
Z-0288-2016 November 25, 2015 Kalona, IA
Medtronic Vascular, Inc.
Class II Terminated
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP0400...
Reason: Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.
Z-0243-2016 November 18, 2015 Santa Rosa, CA
Cook Inc.
Class II Terminated
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Reason: Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation rev...
Z-0244-2016 November 18, 2015 Bloomington, IN
C.R. Bard, Inc.
Class III Terminated
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Reason: Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 ...
Z-0198-2016 November 11, 2015 Covington, GA
CareFusion 303, Inc.
Class II Terminated
SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Reason: CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
Z-0221-2016 November 11, 2015 San Diego, CA
Medtronic Inc.
Class II Terminated
Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard ...
Reason: 64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
Z-0200-2016 November 11, 2015 Saint Paul, MN
Arrow International Inc
Class II Terminated
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet A...
Reason: Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue...
Z-0207-2016 November 11, 2015 Reading, PA
Baxter Healthcare Corp
Class II Terminated
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
Reason: Potential for a leak at the tubing to luer bond.
Z-0132-2016 October 28, 2015 Deerfield, IL
Arrow International Inc
Class II Terminated
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Reason: Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injection...
Z-0127-2016 October 21, 2015 Reading, PA
Concentric Medical Inc
Class II Terminated
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occ...
Reason: One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Z-0116-2016 October 21, 2015 Mountain View, CA
Biosense Webster, Inc.
Class II Terminated
Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Reason: Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the C...
Z-0002-2016 October 7, 2015 Irwindale, CA
Biosense Webster, Inc.
Class II Terminated
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other device...
Reason: Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the C...
Z-0003-2016 October 7, 2015 Irwindale, CA
Bard Access Systems
Class II Terminated
Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
Reason: Bard Access Systems is recalling marketing brochures for the PowerPICC¿ and PowerPICC¿ SOLO¿ catheters due to incorrect indication for use contained in the brochure.
Z-2808-2015 September 30, 2015 Salt Lake City, UT
Zien Medical Technologies, Inc
Class II Terminated
PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
Reason: Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause anal...
Z-2800-2015 September 30, 2015 Salt Lake City, UT
Edward Lifesciences, Llc
Class II Terminated
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requ...
Reason: Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the sys...
Z-2776-2015 September 23, 2015 Irvine, CA
Halyard Health, Inc
Class II Terminated
KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to a...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2513-2015 September 9, 2015 Alpharetta, GA
Covidien LLC
Class II Terminated
Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flu...
Reason: Sterility may be compromised
Z-2534-2015 September 9, 2015 North Haven, CT
Halyard Health, Inc
Class II Terminated
KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as ne...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2521-2015 September 9, 2015 Alpharetta, GA
Volcano Corporation
Class II Terminated
Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer P...
Reason: Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Cathe...
Z-2718-2015 September 9, 2015 Rancho Cordova, CA
C.R. Bard, Inc.
Class II Terminated
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermi...
Reason: Potential breach of the sterile barrier packaging.
Z-2732-2015 September 9, 2015 Covington, GA