CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) a...
Reason: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Z-2137-2024June 19, 2024Princeton, NJ
Integra LifeSciences Corp.
Class IIOngoing
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other ...
Reason: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
Z-2136-2024June 19, 2024Princeton, NJ
Covidien, LLC
Class IIOngoing
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Reason: Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
Z-2038-2024June 19, 2024Santa Clara, CA
Integra LifeSciences Corp.
Class IIOngoing
CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospina...
Reason: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Z-2138-2024June 19, 2024Princeton, NJ
ARROW INTERNATIONAL Inc.
Class IOngoing
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
Reason: Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest a...
Z-1879-2024June 12, 2024Morrisville, NC
Stryker Neurovascular
Class IIOngoing
The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewire...
Reason: Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire...
Z-1941-2024June 12, 2024Fremont, CA
Stryker Neurovascular
Class IIOngoing
The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014in. The gu...
Reason: Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire...
Z-1940-2024June 12, 2024Fremont, CA
ARROW INTERNATIONAL Inc.
Class IOngoing
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Reason: Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest a...
Z-1878-2024June 12, 2024Morrisville, NC
Stryker Neurovascular
Class IIOngoing
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.0...
Reason: Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire...
Z-1939-2024June 12, 2024Fremont, CA
ARROW INTERNATIONAL Inc.
Class IOngoing
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Reason: Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest a...
Z-1880-2024June 12, 2024Morrisville, NC
Stryker Neurovascular
Class IIOngoing
Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238
Reason: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so t...
Z-1904-2024June 5, 2024Fremont, CA
Stryker Neurovascular
Class IIOngoing
Trevo Trak 21 Microcatheter, Catalog: 90338
Reason: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so t...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Z-1653-2024May 22, 2024Maple Grove, MN
Boston Scientific Corporation
Class IOngoing
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...
Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delamina...