Boston Scientific Corporation - Stingray Guidewire - Class 2 Recall
Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2019 Category: Medical Devices Source Type: alerts

Cordis Corporation - POWERFLEX PRO Percutaneous Transluminal Angioplasty (PTA) Catheter - Class 2 Recall
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 obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2018 Category: Medical Devices Source Type: alerts

Cook Inc. - Advance 35LP LowProfile PTA Balloon Dilatation Catheter - Class 2 Recall
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 26, 2018 Category: Medical Devices Source Type: alerts

Medtronic Vascular Galway DBA Medtronic Ireland - Solarice Rapid Exchange Balloon Dilatation Catheter - Class 2 Recall
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2017 Category: Medical Devices Source Type: alerts

Medtronic Vascular Galway DBA Medtronic Ireland - Euphora Rapid Exchange Balloon Dilatation Catheter - Class 2 Recall
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2017 Category: Medical Devices Source Type: alerts

Medtronic Inc., Cardiac Rhythm and Heart Failure - Euphora Rapid Exchange Balloon Dilatation Catheter - Class 2 Recall
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2017 Category: Medical Devices Source Type: alerts

Medtronic Inc., Cardiac Rhythm and Heart Failure - Solarice Rapid Exchange Balloon Dilatation Catheter - Class 2 Recall
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2017 Category: Medical Devices Source Type: alerts

DeRoyal Industries Inc - Dolphin Inflation Device - Class 2 Recall
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2017 Category: Medical Devices Source Type: alerts

Spectranetics Corporation - ELCA Coronary Atherectomy Catheter. - Class 2 Recall
ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts

Spectranetics Corporation - ELCA Coronary Atherectomy Catheter. - Class 3 Recall
ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts

Spectranetics Corporation - Turbo Elite Atherectomy Catheter - Class 2 Recall
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts

Medtronic Vascular, Inc. - Amphirion Deep OTW PTA Balloon Catheter - Class 2 Recall
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080152 AMP253210152 AMP020080152 AMP025080002 AMP030040002 AMP030150152 AMP040120152 AMP335210152 AMP020120152 AMP025080152 AMP030040152 AMP035120152 AMP040150152 AMP354210152; OUS: AMD025150152 AMD030150152 AMD040120002 AMD335210002 AMD030040002 AMD035040152 AMD040120152 AMD335210152 AMD030040152 AMD035120002 AMD040150002 AMD354210002 AMD030080002 AMD035150002 AMD040150152 AMD354210152 AMD030080152 AMD035150152 AMD225210002 AM...
Source: Medical Device Recalls - November 7, 2015 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - AngioJet Spiroflex Thrombectomy Set - Class 2 Recall
AngioJet¿ Spiroflex¿ Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. The AngioJet¿ Spiroflex¿ Thrombectomy Set is intended for: " Breaking apart and removing thrombus from infra-inguinal peripheral arteries e 2.0 mm in diameter. " Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels e 2.0mm in diameter prior to balloon angioplasty or stent placement. The AngioJet¿ SOLENT" Omni Thrombectomy Set is intended for: " Breaking apart and removing thrombus f...
Source: Medical Device Recalls - August 14, 2015 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - AngioJet SOLENT Dista Thrombectomy Set - Class 2 Recall
AngioJet¿ SOLENT" Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. The AngioJet¿ Spiroflex¿ Thrombectomy Set is intended for: " Breaking apart and removing thrombus from infra-inguinal peripheral arteries e 2.0 mm in diameter. " Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels e 2.0mm in diameter prior to balloon angioplasty or stent placement. The AngioJet¿ SOLENT" Omni Thrombectomy Set is intended for: " Breaking apart and removing thrombus from upper a...
Source: Medical Device Recalls - August 14, 2015 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - AngioJet SOLENT Omni Thrombectomy Set - Class 2 Recall
AngioJet¿ SOLENT" Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized Using Ethylene Oxide. The AngioJet¿ Spiroflex¿ Thrombectomy Set is intended for: " Breaking apart and removing thrombus from infra-inguinal peripheral arteries e 2.0 mm in diameter. " Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels e 2.0mm in diameter prior to balloon angioplasty or stent placement. The AngioJet¿ SOLENT" Omni Thrombectomy Set is intended for: " Breaking apart and removing thromb...
Source: Medical Device Recalls - August 14, 2015 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - AngioJet AVX Thrombectomy Set: - Class 2 Recall
AngioJet¿ AVX¿ Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. The AngioJet¿ Spiroflex¿ Thrombectomy Set is intended for: " Breaking apart and removing thrombus from infra-inguinal peripheral arteries e 2.0 mm in diameter. " Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels e 2.0mm in diameter prior to balloon angioplasty or stent placement. The AngioJet¿ SOLENT" Omni Thrombectomy Set is intended for: " Breaking apart and removing thrombus from upper and lowe...
Source: Medical Device Recalls - August 14, 2015 Category: Medical Equipment Source Type: alerts

EXP Pharmaceutical Services Corp - Balloon Catheter - Class 2 Recall
Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 25, 2015 Category: Medical Equipment Source Type: alerts

PEROUSE MEDICAL - Bard - Class 2 Recall
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 30, 2014 Category: Medical Equipment Source Type: alerts

LABORATOIRES PEROUSE - Bard - Class 2 Recall
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 30, 2014 Category: Medical Equipment Source Type: alerts

Medtronic Vascular, Inc. - NC Sprinter; Rapid Exchange Balloon Dilatation Catheter - Class 2 Recall
NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure (see labelling). The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guide wire to position the catheter. Radiopaque ba...
Source: Medical Device Recalls - October 1, 2013 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - Boston Scientific, Small Peripheral Cutting BalloonTM - Class 2 Recall
Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F. 2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # M001PCBO4015140F0, Catalogue # PCBO4015140F. (Source: M...
Source: Medical Device Recalls - September 4, 2013 Category: Medical Equipment Source Type: alerts

Bard Peripheral Vascular Inc - PTA Balloon Dilatation Catheters - Class 2 Recall
BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess¿ PTA Balloon Dilatation Catheters are supplied ...
Source: Medical Device Recalls - June 13, 2013 Category: Medical Equipment Source Type: alerts