Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for t...
Reason: Incorrect (higher) Rated Burst Pressure information printed on label.
Z-0963-2019March 6, 2019Dongguan
Cook Inc.
Class IITerminated
Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of ...
Reason: There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
Z-0968-2019March 6, 2019Bloomington, IN
Abbott Vascular
Class IITerminated
PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation cathet...
Reason: Incorrect expiration being entered for one lot.
Z-0960-2019March 6, 2019Temecula, CA
Boston Scientific Corporation
Class IITerminated
Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and...
Reason: A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Z-0852-2019February 27, 2019Maple Grove, MN
Bard Medical Division
Class IIOngoing
BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for us...
Reason: Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine f...
Reason: potential for urine leakage around the vent on the vented sample port
Z-0803-2019February 13, 2019Covington, GA
Edwards Lifesciences, LLC
Class ITerminated
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determin...
Reason: These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values a...
Z-0763-2019February 6, 2019Irvine, CA
Edwards Lifesciences, LLC
Class ITerminated
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic ...
Reason: These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values a...
Z-0764-2019February 6, 2019Irvine, CA
Edwards Lifesciences, LLC
Class ITerminated
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic p...
Reason: These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values a...
Z-0762-2019February 6, 2019Irvine, CA
Edwards Lifesciences, LLC
Class ITerminated
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pr...
Reason: These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values a...
Z-0765-2019February 6, 2019Irvine, CA
Stryker Sustainability Solutions
Class IITerminated
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can b...
Reason: Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Ele...
Z-0766-2019January 30, 2019Tempe, AZ
Arrow International Inc
Class IITerminated
Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days...
Reason: The lidstock states the incorrect priming volume and flow rates.
Z-0723-2019January 23, 2019Reading, PA
Volcano Corporation
Class IITerminated
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ul...
Reason: Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
Z-0726-2019January 23, 2019Rancho Cordova, CA
Volcano Corporation
Class IITerminated
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ul...
Reason: Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
Z-0727-2019January 23, 2019Rancho Cordova, CA
Boston Scientific Corporation
Class IIIOngoing
IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for...
Reason: Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not refle...
Z-0701-2019January 16, 2019Marlborough, MA
Boston Scientific Corporation
Class IIIOngoing
Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for:...
Reason: Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not refle...
Z-0699-2019January 16, 2019Marlborough, MA
Boston Scientific Corporation
Class IIIOngoing
IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for...
Reason: Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not refle...
Z-0700-2019January 16, 2019Marlborough, MA
COVIDIEN LLC
Class IITerminated
8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
Reason: The product was released into commercial distribution while subject to importation refusal.
Z-0656-2019December 26, 2018Mansfield, MA
Angiodynamics Inc. (Navilyst Medical Inc.)
Class IITerminated
Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
Reason: Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the...
Z-0595-2019December 19, 2018Glens Falls, NY
Atrium Medical Corporation
Class IITerminated
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Reason: This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the po...
Z-0560-2019December 12, 2018Merrimack, NH
Numed Inc
Class IITerminated
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used fo...
Reason: Instructions for Use booklets were not included on the outer pouch
Z-0510-2019December 5, 2018Hopkinton, NY
Numed Inc
Class IITerminated
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used fo...
Reason: Instructions for Use booklets were not included on the outer pouch
Reason: The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather tha...
Z-0468-2019November 21, 2018Reading, PA
Stryker Sustainability Solutions
Class IITerminated
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Reason: Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for ...
Z-0467-2019November 21, 2018Tempe, AZ
Cordis Corporation
Class IITerminated
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obs...
Reason: Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).