Recall archive
138 recalls · page 6 of 6
Reported Jun 24, 2015
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Reason for recall — Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface…
FDA (openFDA device enforcement)
Reported Apr 8, 2015
Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details · Reason for recall — Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2015
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 15, 2014
StarMedTec LightTrail¿ Reusable Fibers, 365 um; Material/Part Number: 6453
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Product is not cleared for use with lasers other than the Auriga XL system
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2014
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2014
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to…
FDA (openFDA device enforcement)
Reported Mar 19, 2014
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health…
FDA (openFDA device enforcement)
Reported Feb 19, 2014
Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details · Reason for recall — Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2014
Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the…
FDA (openFDA device enforcement)
Reported Jan 22, 2014
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
8 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2013
Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2013
Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details · Reason for recall — Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire)…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2013
Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Product details — The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both…
FDA (openFDA device enforcement)
Reported Jul 24, 2013
Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product details · Reason for recall — Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The…
FDA (openFDA device enforcement)
Reported Jul 17, 2013
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Boston Scientific Corporation
Matched: Brand · Product · Product details — Product labeled with incorrect expiration date.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 24, 2012
LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 3, 2012
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greatbatch Medical
Matched: Product · Product details — During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE…
FDA (openFDA device enforcement)
Reported Jun 27, 2012
Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — Difficulty in extending snare loop from the catheter
2 more products in this recall
FDA (openFDA device enforcement)
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