Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1911-2023June 21, 2023South Jordan, UT
Merit Medical Systems, Inc.
Class IIOngoing
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1912-2023June 21, 2023South Jordan, UT
Merit Medical Systems, Inc.
Class IIOngoing
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1920-2023June 21, 2023South Jordan, UT
Merit Medical Systems, Inc.
Class IIOngoing
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1913-2023June 21, 2023South Jordan, UT
C.R. Bard Inc
Class IIOngoing
Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
Reason: Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that co...
Z-1700-2023June 14, 2023Covington, GA
C.R. Bard Inc
Class IIOngoing
Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818
Reason: Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that co...
Z-1698-2023June 14, 2023Covington, GA
C.R. Bard Inc
Class IIOngoing
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
Reason: Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that co...
Z-1701-2023June 14, 2023Covington, GA
C.R. Bard Inc
Class IIOngoing
Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j...
Reason: Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that co...
Z-1699-2023June 14, 2023Covington, GA
Access Vascular, Inc
Class IIOngoing
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Reason: The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.
Z-1605-2023May 24, 2023Billerica, MA
Abiomed, Inc.
Class IOngoing
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart As...
Reason: The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Z-1590-2023May 24, 2023Danvers, MA
Boston Scientific Corporation
Class IIOngoing
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and bili...
Reason: Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tiss...
Reason: There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error...
Z-1379-2023April 19, 2023Irvine, CA
Merit Medical Systems, Inc.
Class IIOngoing
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Reason: Product that was built for design verification testing was inadvertently distributed to customers.
Reason: There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error...
Z-1380-2023April 19, 2023Irvine, CA
Elekta Instrument AB
Class IIOngoing
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlu...
Reason: The incorrect IFU was distributed with the devices.
Z-1309-2023April 5, 2023Stockholm, N/A
Datascope Corp.
Class IIOngoing
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
Reason: There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure o...
Reason: There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure o...
Z-1276-2023March 29, 2023Mahwah, NJ
Datascope Corp.
Class IIOngoing
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Reason: There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure o...
Z-1279-2023March 29, 2023Mahwah, NJ
Datascope Corp.
Class IIOngoing
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Reason: There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure o...
Reason: Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and m...
Z-1249-2023March 22, 2023West Valley City, UT
Access Vascular, Inc
Class IIOngoing
HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
Reason: Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Z-1131-2023February 22, 2023Billerica, MA
Access Vascular, Inc
Class IIOngoing
HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Reason: Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Z-1130-2023February 22, 2023Billerica, MA
Access Vascular, Inc
Class IIOngoing
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Reason: Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Reason: Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).
Z-1051-2023February 8, 2023Tempe, AZ
SunMed Holdings, LLC
Class IIOngoing
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0...
Reason: There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through ...