The lead caps available in Medtronic Deep Brain Stimulation dystonia therapy kits and lead kits have been recalled due to the potential damage that could be had in said component.  Medtronic announced the recall following the discovery that connector twisting in the midst of a brain operation could lead to said damage.  This could compromise the patient’s ability to receive adequate therapy.  Medtronic has submitted a proposed alteration to the manufacturing procedure that they hope to receive FDA approval of.  In the meantime, doctors are being instructed on how to properly use these devices, and if any adversity is presented, a report should be filed with MedWatch.

To learn more about the recall, click here.

HT70 and HT70 Plus Ventilators are being recalled by Newport Medical Instruments because of an issue that could compromise patient safety.  On units with Power Pac batteries that have serial numbers between 2096134110001 and 2292048120050, an alarm can go off and prompt the unit to work off of an internal battery prematurely.  When the device operates off of this type of battery power, the patient is at greater risk of sustaining a serious injury or even a fatality.  The issue can take the form of the screen mistakenly proclaiming that the Power Pac battery is charged or the unit simply switching to the backup battery the moment it’s taken off of AC power.  The company can be contacted by affected parties, at which point new batteries will be provided.

For more about the recall, click here.

13086, 13087, 13088, 13150, 13100, and 13000 models of GemStar Infusion Systems have been recalled by Hospira because of an issue that could prevent the continued operational capacity of the device.  Used to provide infusion in a home or hospital setting, the devices could potentially sustain an 11/004 error when the lithium battery is lower than 2.4 volts.  As a result, the product would cease to function and the patient would not receive the therapy they require.  Plus, the device’s memory will be wiped of previous settings and a recording of events.  Owners of the devices, which were available between February 1999 and this month, are advised to get in touch with Hospira to learn if they should replace their battery.  This replacement should typically be sought if the battery is more than three years old.

For more about the recall, click here.

Versions of the Alaris PC Unit (a component of the Alaris electronic infusion pump) with a software level of 9.12 are being recalled by CareFusion Corporation because of the possibility of a Communications Error.  This situation presents itself when the user toggles between different screens.  An alarm accompanied by a blinking red light will emanate, at which point users will be unable to execute commands on the device other than to turn it off completely.  Infusion will continue during the error mode, but once the item is turned off, even this will cease.  Medical professionals are being asked to weigh the risks against the benefits of disabling the device before they take action.  If they determine that the product poses too great of a threat, then it should not be used until such time that CareFusion can offer repairs.

Click to learn more about the recall.

ShapeMatch Cutting Guides used during total knee replacement surgeries have been recalled by Stryker because the products could allow for cutting ranges that are greater than what is acceptable during the procedure.  Because of a software defect, the actual parameters of the guide might not be in line with what the surgeon planned prior to the operation, or they might display information that also doesn’t match what is actually produced.  44 incidents have been reported, three of which caused injuries that were apparently treated shortly after the inappropriate cut.  A patient privy to such an error could face a fracture, instability of their joint, and severe pain and mobility reduction that could prompt a revision surgery.  Any person who recently underwent a knee replacement surgery should speak with their doctor the moment they start to feel any of the aforementioned issues.

To learn more about the recall, click here.

2020 Infusion Insulin Pumps have been recalled by Animas because there’s a chance that they could emit a warning alarm unnecessarily, a condition which might put the patient at risk.  Used to facilitate the delivery of insulin to persons who suffer from diabetes, each affected product would have been produced between March 1 and November 30 of last year.  Three separate alerts might appear because of the defect.  Each could trigger a warning from the pump asking the user to initiate a rewind, load, and prime sequence.  If this process is mistakenly carried out while the user is still connected to the device, he or she is susceptible to hypoglycemia because of a potential accidental delivery of insulin.  The items also will cease working in 2016 because of a software issue.  A free new pump can be obtained by contacting Animas.

Click here for more about the recall.

LifeScan has announced the recall of blood glucose meters under the OneTouch VerioIQ brand because of a potential sudden shutoff risk.  The Johnson and Johnson subsidiary issued the recall, which affects upward of 90,000 glucose meters, once it was discovered that incredibly heightened readings could trigger the device’s shutdown.  The level of glucose has to clock in at 1024 milligrams/dl for the condition to present itself.  This amount is fairly rare, but because the issue could cause necessary treatment to be delayed, or even incorrectly administered, the recall was issued.  In such instances, the patient would not be told of their high glucose levels.  Consumers are being asked to get in touch with the company for a free meter that doesn’t suffer from the defect.

Click here for more about the recall.

Spacelabs Medical has announced the recall of BleaseFocus and BleaseSirius Anesthesia Workstations because of an issue with the way anesthetics or oxygen are delivered to the patient.  The defect exists in the CAS I/II Absorbers contained within the workstations.  Because of the problem, the air being provided to the patient could experience an overabundance of carbon dioxide, something that could cause an injury or a fatality.  The items in question were made available to healthcare facilities starting on October 31 and leading all the way up to January 15.  Medical professionals are being asked to cease respiration administration with this device and get in touch with Spacelabs to learn about remedy options.

For more about the recall, click here.

The threat of an air leakage, and in turn an embolism, has prompted the recall of Guardian II NC and Guardian II hemostasis valves.  These items, which are used as a component in catheterization operations, were recalled by the Minneapolis, Minnesota-based Vascular Solutions Zerusa.  The valves were made available to healthcare professionals and in turn patients between February of last year and February of this year.  If the implanted item leaks air and leads the patient to suffer an air embolism, he or she could incur a severe injury which could prove fatal.  No one has reported such an injurious incident at this point in time.  The products should not be used and should instead be returned to Vascular Solutions.

Follow this link to learn more about the recall.

Macro Micro Subdural Electrodes are being recalled by the Ad-Tech Medical Instrument Corporation because of a defect that could compromise patient safety.  Although originally issued in December, the FDA is just now making the announcement known.  On 115 of these devices, the microelectrodes might not be placed right up against the silastic surface of the items.  Cortical brain tissue could thus suffer from an abrasion, and the removal of the electrode could also lead to fractured pieces being left behind.  The resultant hemorrhage or cortical fiber damage could lead the patient to experience a seizure or infarction.  Available up until March of last year, the items should be returned to Ad-Tech, which is making arrangements for such.  One serious injury has already been reported to the company.

For more about the recall, follow this link.

The threat of an air embolism has prompted the recall of a certain medical device by Lumenis Limited.  The company issued the recall in regards to their VersaCut Morcellator device, which is used during surgery to aid in the process of breaking up and removing dissected tissue.  Unfortunately, if a healthcare professional links the aspiration tubing to the control box housing in a backwards manner, the aforementioned air embolism becomes a possibility.  This could lead the patient to suffer serious side effects or even a fatality.  A new operator’s manual is being given to healthcare facilities that use the products, and the company is also handing over new labels which are to be affixed to the devices.

Click here for more about the recall.

St. Jude Medical has announced the recall of its AMPLATZER TorqVue FX Delivery Systems.  These items are used during procedures involving the Amplatzer Occluder, a device designed to allow doctors to close up openings in the heart’s upper chambers.  Unfortunately, certain circumstances could lead a portion of this product to experience a fracture that would compromise the safety of the patient.  All versions of this item are being recalled, and each would have been made available to healthcare practitioners between October of last year and this past January 9.  Doctors are being advised to immediately remove the devices from service.  Any adversity associated with the device should be reported to Medwatch.

Click here for more about the recall.

Grab ‘n Go Vantage portable oxygen cylinder units are being recalled by Praxair because of a safety issue that could result should the item be handled incorrectly.  Should a harsh impact affect these units, whether due to the cylinder being dropped or otherwise knocked to the side, the interior components could ignite.  Praxair says that a certain o-ring increases the risk of such an incident, which has already been reported a few times.  Replacement of this component is being carried out as necessary when affected individuals bring their cylinders in for routine service.  Praxair says that more than half of all such affected units have already been fixed, and these repaired versions can be identified by the letter T on an affixed decal.

For more about the recall, click here.

A disposable T-Piece circuit meant to be used in conjunction with the Panda and Giraffe Resuscitation System is being recalled by GE Healthcare because there’s a chance that this component cannot produce the requisite positive inspiratory pressure that would allow intense resuscitation.  This could lead the patient to experience serious complications or even a fatality.  The item, which is designed to be used for infant pulmonary resuscitation, should not be used if the needed inspiratory pressure levels cannot be met.  Doctors are being asked to dispose of those versions of the circuit that have a red inspection stamp affixed.

Click here for more about the recall.

A ventilator meant to be used by infant patients is being recalled because of a spark and smoke threat that could lead to further serious and potentially fatal complications.  Bunnell announced the recall, which pertains to their Life Pulse High-Frequency Ventilator Patient Circuits.  The insulation of the heater wires within these devices could melt, and if that were to occur, sparks and smoke may result.  The infant hooked up to the system would have his or her safety compromised thusly.  The circuits were available between March 19 and October.  Doctors should have received a letter about the issue in November, and that letter reportedly contained instructions on what to do.  The company has not offered to give medical professionals replacement units yet.

For more about the recall, click here.

A packaging issue has led to the recall of SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin from Ethicon.  Produced between September 16 of last year and July 27 of this year, these items are being recalled because a cut made during the packaging process could have compromised the product’s double Tyvek pouch.  The items, which are typically used during surgery to staunch the flow of bleeding, are being described as potentially leading to serious injuries or even a fatality.  Ethicon reportedly first notified consumers of the issue back in August.  Any incidents of adversity should be reported to the FDA through their MedWatch program.

Click here for more about the recall.

Stericycle, acting on behalf of medical device manufacturer Hospira, has announced the recall of Symbiq infusion pumps.  These prescription items, which are meant to provide fluids and medications to patients by way of an epidural, intravenous, or similar lead, work by way of a touchscreen that controls the necessary settings.  Unfortunately, it’s been discovered that the touchscreens might not respond properly to input from the user.  As such, different values could be selected or there could be a delay in administration.  A letter has been sent to affected consumers explaining how to ensure the problem doesn’t compromise safety.

To learn more about the recall, follow this link.

Ethicon TRANSTAR and PROXIMATE circular staplers used during surgical procedures meant to correct hemorrhoids and prolapses are being recalled due to the danger they could pose if not used accurately.  It’s been shown that doctors utilizing these devices might find it difficult to fire the staples adequately, which could lead the staple not to form completely.  For the patient, that could mean intense pain, bleeding, sepsis, and more.  Those with the medical device in their possession will receive a notification with instructions on what to do.

For more about the recall, click here.

14,602 manual resuscitators have been recalled by the Ventlab Corporation.  These resuscitators, which were available between March and July of this year, might not deliver the requisite amount of air to a patient in need of the device.  Hypoventilation and hypoxia could then become a distinct possibility, and the issue could even be lethal.  Thankfully, no one has reported any type of injury at this point in time, and the company that initiated the recall is in the process of providing users with a remedy.

Follow this link for more about the recall.

Medical professionals are being warned about the potential danger that exists with Hemostatic Bone Putty from Synthes.  This substance, which is used during surgery to halt bleeding of the bones that were traumatized or lacerated during a procedure, can catch fire if brought into contact with some kind of electrical cauterization device.  The putty has since been recalled, and any remaining putty should not be used but instead returned to Synthes.

Click here to learn more about the threat.