Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 31 of 138
Cook Incorporated
Class II Ongoing
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures...
Reason: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Z-1708-2022 September 21, 2022 Bloomington, IN
Cook Incorporated
Class II Ongoing
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional p...
Reason: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Z-1714-2022 September 21, 2022 Bloomington, IN
Biosense Webster, Inc.
Class II Ongoing
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Reason: Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product...
Z-1677-2022 September 14, 2022 Irwindale, CA
Datascope Corporation
Class II Ongoing
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Reason: Certain lots containing undersized dilator.
Z-1687-2022 September 14, 2022 Fairfield, NJ
Datascope Corporation
Class II Ongoing
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Reason: Certain lots containing undersized dilator.
Z-1685-2022 September 14, 2022 Fairfield, NJ
Datascope Corporation
Class II Ongoing
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Reason: Certain lots containing undersized dilator.
Z-1686-2022 September 14, 2022 Fairfield, NJ
Mckesson Medical-Surgical Inc. Corporate Office
Class II Ongoing
MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Model Number: DYND10160
Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0...
Z-1609-2022 August 31, 2022 Richmond, VA
Mckesson Medical-Surgical Inc. Corporate Office
Class II Ongoing
MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number: DYND12200
Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0...
Z-1610-2022 August 31, 2022 Richmond, VA
Boston Scientific Corporation
Class II Ongoing
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Reason: The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
Z-1582-2022 August 31, 2022 Maple Grove, MN
Mckesson Medical-Surgical Inc. Corporate Office
Class II Ongoing
Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0...
Z-1613-2022 August 31, 2022 Richmond, VA
Mckesson Medical-Surgical Inc. Corporate Office
Class II Ongoing
TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0...
Z-1604-2022 August 31, 2022 Richmond, VA
Micro Therapeutics, Inc.
Class II Ongoing
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Reason: Outer carton packaging of microcatheters were exposed to wet substance during transport.
Z-1556-2022 August 24, 2022 Irvine, CA
Siemens Medical Solutions USA, Inc
Class III Terminated
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641...
Reason: The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the pat...
Z-1558-2022 August 24, 2022 Malvern, PA
Micro Therapeutics, Inc.
Class II Ongoing
Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
Reason: Outer carton packaging of microcatheters were exposed to wet substance during transport.
Z-1557-2022 August 24, 2022 Irvine, CA
Medtronic Inc
Class II Ongoing
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
Reason: Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Z-1483-2022 August 10, 2022 Minneapolis, MN
Siemens Medical Solutions USA, Inc
Class II Ongoing
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology M...
Reason: Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivit...
Z-1425-2022 July 27, 2022 Malvern, PA
Stryker Neurovascular
Class II Ongoing
Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X...
Reason: Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
Z-1386-2022 July 27, 2022 Fremont, CA
Siemens Medical Solutions USA, Inc
Class II Ongoing
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Rad...
Reason: Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivit...
Z-1426-2022 July 27, 2022 Malvern, PA
Cook Incorporated
Class II Completed
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Reason: The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used inc...
Z-1362-2022 July 20, 2022 Bloomington, IN
Abbott
Class II Ongoing
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Reason: When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, o...
Z-1344-2022 July 13, 2022 Plymouth, MN
Covidien Llc
Class I Ongoing
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Reason: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated flu...
Z-1312-2022 July 13, 2022 Mansfield, MA
Covidien Llc
Class I Ongoing
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Reason: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated flu...
Z-1313-2022 July 13, 2022 Mansfield, MA
Covidien Llc
Class I Ongoing
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Reason: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated flu...
Z-1317-2022 July 13, 2022 Mansfield, MA
Covidien Llc
Class I Ongoing
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Reason: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated flu...
Z-1319-2022 July 13, 2022 Mansfield, MA
Covidien Llc
Class I Ongoing
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Reason: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated flu...
Z-1316-2022 July 13, 2022 Mansfield, MA