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...
Z-1655-2024May 22, 2024Maple Grove, MN
Sophysa S.A.
Class IIOngoing
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventric...
Reason: An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could p...
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...
Z-1681-2024May 22, 2024Maple Grove, MN
Boston Scientific Corporation
Class IOngoing
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; 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...
Z-1676-2024May 22, 2024Maple Grove, MN
Stryker Neurovascular
Class IIOngoing
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophil...
Reason: Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was re...
Z-1740-2024May 8, 2024Fremont, CA
ROUTE 92 MEDICAL INC
Class IOngoing
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Z-1614-2024May 1, 2024San Mateo, CA
Covidien LP
Class IIOngoing
Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion...
Reason: Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Z-1635-2024May 1, 2024Mansfield, MA
ROUTE 92 MEDICAL INC
Class IOngoing
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Z-1612-2024May 1, 2024San Mateo, CA
ROUTE 92 MEDICAL INC
Class IOngoing
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Z-1611-2024May 1, 2024San Mateo, CA
Covidien LP
Class IIOngoing
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialy...
Reason: Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Z-1634-2024May 1, 2024Mansfield, MA
ROUTE 92 MEDICAL INC
Class IOngoing
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Z-1613-2024May 1, 2024San Mateo, CA
ROUTE 92 MEDICAL INC
Class IOngoing
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Z-1610-2024May 1, 2024San Mateo, CA
Cook Incorporated
Class IIOngoing
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. RE...
Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1528-2024April 24, 2024Bloomington, IN
Cook Incorporated
Class IIOngoing
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFE...
Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1529-2024April 24, 2024Bloomington, IN
Cook Incorporated
Class IIOngoing
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the...
Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility