BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample co...
Reason: May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead ...
Reason: The firm received reports indicating PTD tip separation during use.
Z-0624-2022February 23, 2022Morrisville, NC
TELEFLEX MEDICAL INC
Class ITerminated
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rota...
Reason: The firm received reports indicating PTD tip separation during use.
Z-0629-2022February 23, 2022Morrisville, NC
TELEFLEX MEDICAL INC
Class ITerminated
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunct...
Reason: The firm received reports indicating PTD tip separation during use.
Reason: The firm received reports indicating PTD tip separation during use.
Z-0626-2022February 23, 2022Morrisville, NC
Covidien Llc
Class IIOngoing
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
Reason: The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remo...
Z-0557-2022February 9, 2022Mansfield, MA
Siemens Medical Solutions USA, Inc
Class IIOngoing
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis ...
Reason: Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other ...
Reason: Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Z-0450-2022January 26, 2022Plymouth, MN
ev3 Inc.
Class ITerminated
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional ather...
Reason: Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Z-0451-2022January 26, 2022Plymouth, MN
Canon Medical System, USA, INC.
Class IIOngoing
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Reason: Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working wit...
Z-0492-2022January 19, 2022Tustin, CA
Cardiovascular Systems Inc
Class ITerminated
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Reason: Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device...
Z-0394-2022December 29, 2021Saint Paul, MN
Becton Dickinson Infusion Therapy Systems Inc.
Class IIOngoing
BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD...
Reason: There is a breach in the product packaging that renders the product non-sterile.
Z-0306-2022December 1, 2021Sandy, UT
Arrow International Inc
Class ITerminated
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the A...
Reason: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent ...
Z-0233-2022November 24, 2021Reading, PA
Arrow International Inc
Class ITerminated
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the ...
Reason: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent ...
Z-0231-2022November 24, 2021Reading, PA
Cook Inc.
Class IITerminated
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
Reason: Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used r...
Z-0223-2022November 24, 2021Bloomington, IN
Arrow International Inc
Class ITerminated
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with th...
Reason: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent ...
Z-0232-2022November 24, 2021Reading, PA
Arrow International Inc
Class ITerminated
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the ...
Reason: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent ...
Z-0234-2022November 24, 2021Reading, PA
Siemens Medical Solutions USA, Inc
Class IIOngoing
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administr...
Reason: System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more th...
Reason: The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of ...
Z-0210-2022November 17, 2021Mansfield, MA
W L Gore & Associates, Inc.
Class IIOngoing
REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
Reason: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.