Recall archive
141 recalls · page 3 of 6
Reported Sep 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product details · Reason for recall — There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2022
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
FDA (openFDA device enforcement)
Reported Aug 10, 2022
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Product may be mislabeled.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Boston Scientific Corporation
Matched: Brand — Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS…
FDA (openFDA device enforcement)
Reported May 25, 2022
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical…
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 4, 2022
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2022
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Pouch seals may be open, compromising sterility.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Sterility of device is compromised due to a sterile barrier breach
30 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal…
FDA (openFDA device enforcement)
Reported Dec 8, 2021
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 25, 2021
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Potential for leaks and loosening at the patient catheter connection
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 21, 2021
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 14, 2021
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time…
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 26, 2021
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — The firm has received reports of stent migration after implantation
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 5, 2021
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 28, 2021
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
FDA (openFDA device enforcement)
Reported Apr 21, 2021
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 10, 2021
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
EMBLEM S-ICD Model A209
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — Electrical overstress may lead to device malfunction.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 3, 2021
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand · Product · Product details — Accelerated battery depletion may result in a need for device replacement earlier than expected.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 27, 2021
ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston…
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 (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
Matched: Brand — Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 13, 2021
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 6, 2021
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Brand — Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
1 more product in this recall
FDA (openFDA device enforcement)
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