Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 81 of 138
Stryker Neurovascular
Class II Terminated
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Reason: There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance bet...
Z-2569-2018 August 8, 2018 Fremont, CA
Galt Medical Corporation
Class II Terminated
1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002...
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-2560-2018 August 8, 2018 Garland, TX
Edwards Lifesciences, LLC
Class II Terminated
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Reason: SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Z-2435-2018 July 25, 2018 Irvine, CA
Arrow International Inc
Class II Terminated
VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the ...
Reason: Product pouch label may not easily identify the lot number, expiration date and associated symbols..
Z-2384-2018 July 18, 2018 Reading, PA
Stryker Sustainability Solutions
Class II Terminated
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for elect...
Reason: Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
Z-2426-2018 July 18, 2018 Tempe, AZ
Arrow International Inc
Class II Terminated
Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to o...
Reason: Product pouch label may not easily identify the lot number, expiration date and associated symbols..
Z-2385-2018 July 18, 2018 Reading, PA
Arrow International Inc
Class II Terminated
VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip...
Reason: Product pouch label may not easily identify the lot number, expiration date and associated symbols..
Z-2383-2018 July 18, 2018 Reading, PA
Arrow International Inc
Class II Terminated
VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wav...
Reason: Product pouch label may not easily identify the lot number, expiration date and associated symbols..
Z-2382-2018 July 18, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by ...
Reason: The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and t...
Z-2336-2018 July 11, 2018 Reading, PA
PENTAX of America Inc
Class II Terminated
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
Reason: The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be ...
Z-2256-2018 June 27, 2018 Redwood City, CA
Vascular Solutions, Inc.
Class II Terminated
Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations a...
Reason: The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxi...
Z-2249-2018 June 27, 2018 Maple Grove, MN
C.R. Bard, Inc.
Class II Terminated
Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
Reason: Foley Catheter with Incorrect Retainer Cap Print
Z-2064-2018 June 13, 2018 Covington, GA
CareFusion 303, Inc.
Class II Terminated
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's...
Reason: Reports of incorrect priming volume due to manufacturing with incorrect tubing.
Z-2111-2018 June 13, 2018 San Diego, CA
Arrow International Inc
Class II Terminated
Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1988-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1973-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
TheraCath(R) Epidural Catheter; Product Code: EC-05000
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2012-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1999-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1976-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1978-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2017-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1998-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1972-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2018-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2006-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
8Fr. Catheter Clamp with Fastener; Product Code: CC-00008
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2009-2018 June 6, 2018 Reading, PA