Medical device recalls

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.

Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

There is a material mislabeling of the AFN End Cap.

Obstructed/blocked port from defective VGC Access Port Body component.

GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR ¿ 1020.40(c)(1)(i)) underneath the bottom center of the system. The crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed.

Instruments may, under certain specific circumstances listed below, fail to stop when a test is initiated and no sample is present (proximity shut down fails to end test).

A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK¿ 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI).

The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ¿g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.

An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ¿g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.

Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub). The complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch. This was the only complaint received for this non-conformance.

The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.

Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.

Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the TBA.

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.