WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused b...
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Z-3268-2024October 2, 2024Marlborough, MA
Boston Scientific Corporation
Class IIOngoing
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by ...
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Z-3283-2024October 2, 2024Marlborough, MA
Boston Scientific Corporation
Class IIOngoing
AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal stricture...
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Z-3291-2024October 2, 2024Marlborough, MA
Boston Scientific Corporation
Class IIOngoing
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by ...
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Z-3286-2024October 2, 2024Marlborough, MA
Boston Scientific Corporation
Class IIOngoing
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused b...
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Z-3270-2024October 2, 2024Marlborough, MA
Boston Scientific Corporation
Class IIOngoing
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused ...
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Z-3271-2024October 2, 2024Marlborough, MA
Boston Scientific Corporation
Class IIOngoing
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Z-3147-2024September 25, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Z-3148-2024September 25, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Z-3149-2024September 25, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Z-3150-2024September 25, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Z-3151-2024September 25, 2024Maple Grove, MN
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) ENDO KIT, Pack Number DYKE1487C; 4) BRONCH ENDO W/O...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Z-3012-2024September 18, 2024Northfield, IL
Bard Peripheral Vascular Inc
Class IIOngoing
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instruction...
Reason: Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the dist...
Z-3062-2024September 18, 2024Tempe, AZ
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4)...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Z-2992-2024September 18, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3"...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Z-3020-2024September 18, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J;...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Z-2993-2024September 18, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pac...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Z-2997-2024September 18, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRAS...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Z-3010-2024September 18, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185;...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU e...
Z-2957-2024September 11, 2024Danvers, MA
Abiomed, Inc.
Class IIOngoing
Impella 5.5 Set AU; Product Code: 1000361;
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU e...
Z-2968-2024September 11, 2024Danvers, MA
Abiomed, Inc.
Class IIOngoing
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU e...
Z-2965-2024September 11, 2024Danvers, MA
Abiomed, Inc.
Class IIOngoing
Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU e...
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU e...