Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 80 of 138
Stryker Neurovascular
Class II Terminated
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE045...
Reason: Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
Z-3020-2018 September 19, 2018 Fremont, CA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Class II Terminated
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Reason: The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excise...
Z-3022-2018 September 19, 2018 Irvine, CA
Medical Components, Inc dba MedComp
Class II Terminated
Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
Reason: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br...
Z-2932-2018 September 5, 2018 Harleysville, PA
Medical Components, Inc dba MedComp
Class II Terminated
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
Reason: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br...
Z-2940-2018 September 5, 2018 Harleysville, PA
Medical Components, Inc dba MedComp
Class II Terminated
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
Reason: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br...
Z-2936-2018 September 5, 2018 Harleysville, PA
Medical Components, Inc dba MedComp
Class II Terminated
Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits
Reason: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br...
Z-2934-2018 September 5, 2018 Harleysville, PA
Medical Components, Inc dba MedComp
Class II Terminated
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
Reason: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br...
Z-2939-2018 September 5, 2018 Harleysville, PA
Medline Industries Inc
Class II Terminated
Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
Reason: Packaged with an incorrect overwrap.
Z-2948-2018 September 5, 2018 Northfield, IL
Medical Components, Inc dba MedComp
Class II Terminated
Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
Reason: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br...
Z-2938-2018 September 5, 2018 Harleysville, PA
Medical Components, Inc dba MedComp
Class II Terminated
DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
Reason: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br...
Z-2941-2018 September 5, 2018 Harleysville, PA
Medical Components, Inc dba MedComp
Class II Terminated
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
Reason: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br...
Z-2933-2018 September 5, 2018 Harleysville, PA
Medical Components, Inc dba MedComp
Class II Terminated
Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
Reason: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br...
Z-2935-2018 September 5, 2018 Harleysville, PA
Medical Components, Inc dba MedComp
Class II Terminated
DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERS...
Reason: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br...
Z-2942-2018 September 5, 2018 Harleysville, PA
Medical Components, Inc dba MedComp
Class II Terminated
Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
Reason: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br...
Z-2937-2018 September 5, 2018 Harleysville, PA
Vyaire Medical
Class I Terminated
The Tri-Flo Subglottic Suction System
Reason: Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as ...
Z-2826-2018 August 29, 2018 Mettawa, IL
Arrow International Inc
Class II Terminated
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the cent...
Reason: One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it ...
Z-2886-2018 August 29, 2018 Reading, PA
Civco Medical Instruments Co. Inc.
Class II Terminated
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide ...
Reason: A cover failed leak testing during validation testing of new needle guides from a replacement tool.
Z-2888-2018 August 29, 2018 Kalona, IA
Cook Inc.
Class II Terminated
VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavi...
Reason: This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflamm...
Z-2791-2018 August 22, 2018 Bloomington, IN
Merit Medical Systems, Inc.
Class II Terminated
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck¿ PD Catheter can be implanted ...
Reason: Mix-up between adult and pediatrics PD catheter.
Z-2823-2018 August 22, 2018 South Jordan, UT
ConvaTec, Inc
Class II Terminated
AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring d...
Reason: Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
Z-2744-2018 August 22, 2018 Greensboro, NC
Arrow International Inc
Class II Terminated
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venou...
Reason: The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
Z-2819-2018 August 22, 2018 Reading, PA
Arrow International Inc
Class II Terminated
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous...
Reason: The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
Z-2818-2018 August 22, 2018 Reading, PA
Boston Scientific Corporation
Class II Terminated
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed ...
Reason: Potential polymer material degradation.
Z-2735-2018 August 15, 2018 Maple Grove, MN
Arrow International Inc
Class II Terminated
Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous ac...
Reason: Product contains dry natural rubber latex. Label states Latex Free.
Z-2576-2018 August 8, 2018 Reading, PA
Galt Medical Corporation
Class II Terminated
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Reason: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bact...
Z-2563-2018 August 8, 2018 Garland, TX