Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 117 of 138
Medline Industries Inc
Class II Terminated
Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called ...
Reason: The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have s...
Z-2458-2015 September 2, 2015 Mundelein, IL
Arrow International Inc
Class II Terminated
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
Reason: the catheter peel-away component hub tabs may prematurely detach. One injury reported.
Z-2462-2015 September 2, 2015 Reading, PA
Baxter Healthcare Corp.
Class II Terminated
MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect ...
Reason: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid fun...
Z-2471-2015 September 2, 2015 Deerfield, IL
Cordis Corporation
Class II Terminated
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
Reason: Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or...
Z-2405-2015 August 26, 2015 Miami Lakes, FL
C.R. Bard, Inc.
Class II Terminated
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.
Reason: Potential breach of the sterile barrier packaging.
Z-2384-2015 August 26, 2015 Covington, GA
C.R. Bard, Inc.
Class II Terminated
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
Reason: Potential breach of the sterile barrier packaging.
Z-2388-2015 August 26, 2015 Covington, GA
C.R. Bard, Inc.
Class II Terminated
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
Reason: Potential breach of the sterile barrier packaging.
Z-2386-2015 August 26, 2015 Covington, GA
C.R. Bard, Inc.
Class II Terminated
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermittent catheter.
Reason: Potential breach of the sterile barrier packaging.
Z-2387-2015 August 26, 2015 Covington, GA
C.R. Bard, Inc.
Class II Terminated
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
Reason: Potential breach of the sterile barrier packaging.
Z-2385-2015 August 26, 2015 Covington, GA
B. Braun Interventional Systems
Class II Terminated
Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to t...
Reason: The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
Z-2382-2015 August 19, 2015 Minneapolis, MN
Merit Medical Systems, Inc.
Class II Terminated
ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
Reason: Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the actual devic...
Z-2352-2015 August 19, 2015 South Jordan, UT
Cook Inc.
Class I Terminated
Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. T...
Reason: Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occlud...
Z-2319-2015 August 12, 2015 Bloomington, IN
Atrium Medical Corporation
Class II Terminated
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Reason: Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
Z-2346-2015 August 12, 2015 Hudson, NH
Merge Healthcare, Inc.
Class II Terminated
Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and r...
Reason: A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab.
Z-2347-2015 August 12, 2015 Hartland, WI
Cook Inc.
Class I Terminated
Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or ste...
Reason: Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occlud...
Z-2317-2015 August 12, 2015 Bloomington, IN
Cook Inc.
Class I Terminated
Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusi...
Reason: Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occlud...
Z-2318-2015 August 12, 2015 Bloomington, IN
EXP Pharmaceutical Services Corp
Class II Terminated
Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Boston Scientific (OEM) Wire, guide, catheter
Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were r...
Z-2235-2015 August 5, 2015 Fremont, CA
EXP Pharmaceutical Services Corp
Class II Terminated
Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were r...
Z-2234-2015 August 5, 2015 Fremont, CA
EXP Pharmaceutical Services Corp
Class II Terminated
Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Cathete...
Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re...
Z-2245-2015 August 5, 2015 Fremont, CA
EXP Pharmaceutical Services Corp
Class II Terminated
Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) C...
Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re...
Z-2251-2015 August 5, 2015 Fremont, CA
EXP Pharmaceutical Services Corp
Class II Terminated
Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were r...
Z-2233-2015 August 5, 2015 Fremont, CA
Cook Inc.
Class II Terminated
Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional dev...
Reason: Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.
Z-2101-2015 July 29, 2015 Bloomington, IN
American Catheter Corp
Class II Terminated
American Catheter / Cholangiogram Catheter 9100 Series.
Reason: Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
Z-2191-2015 July 29, 2015 Ocala, FL
EKOS Corporation
Class II Terminated
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three m...
Reason: The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
Z-2148-2015 July 29, 2015 Bothell, WA
Cook Inc.
Class II Terminated
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The ...
Reason: Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.
Z-2100-2015 July 29, 2015 Bloomington, IN