Medical device recalls: August 2017
The FDA posted 23 medical device recall records in August 2017, from 13 recall events by 13 companies. 2 are Class I, the most serious category.
Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.
Companies with the most recall events
- GE Medical Systems, LLC · 1 event, 9 records
- Boston Scientific Corporation · 1 event, 3 records
- Alcon Research, LTD. · 1 event, 1 record
- C.R. Bard, Inc. · 1 event, 1 record
- Cardinal Health 200, LLC · 1 event, 1 record
- Cook Medical Incorporated · 1 event, 1 record, 1 Class I
- Custom Assemblies Inc · 1 event, 1 record
- Magellan Diagnostics, Inc. · 1 event, 1 record
FDA root cause
- Mixed-up of materials/components · 9
- Software design · 3
- Nonconforming Material/Component · 3
- Process control · 2
- Material/Component Contamination · 2
- Device Design · 2
- Unknown/Undetermined by firm · 1
- Process design · 1
Class I recalls (2)
The most serious: a reasonable probability that using the device will cause serious health problems or death.
- Z-3106-2017 · Spectranetics Corporation · posted Aug 26, 2017 · Terminated
Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
- Z-2099-2017 · Cook Medical Incorporated · posted Aug 10, 2017 · Terminated
There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.
Class II recalls (21)
The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- Z-3080-2017 · Vyaire Medical · posted Aug 28, 2017 · Terminated
Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
- Alcon Custom Pak ↗Class IIZ-0053-2018 · Alcon Research, LTD. · posted Aug 25, 2017 · Terminated
Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
- Z-3212-2017 · Teleflex Medical · posted Aug 25, 2017 · Terminated
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
- Z-3059-2017 · Custom Assemblies Inc · posted Aug 22, 2017 · Terminated
The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during…
- Z-3105-2017 · Merge Healthcare, Inc. · posted Aug 18, 2017 · Terminated
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
- Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx.Class IIZ-3127-2017 · Orthofix, Inc · posted Aug 18, 2017 · Terminated
The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.
- Z-3037-2017 · Boston Scientific Corporation · posted Aug 16, 2017 · Terminated
The device can deliver an atypical amount of energy due to memory corruption inside the device.
- Z-3038-2017 · Boston Scientific Corporation · posted Aug 16, 2017 · Terminated
The device can deliver an atypical amount of energy due to memory corruption inside the device.
- SQ-RX 1010 Pulse Generator, Rx.Class IIZ-3039-2017 · Boston Scientific Corporation · posted Aug 16, 2017 · Terminated
The device can deliver an atypical amount of energy due to memory corruption inside the device.
- Z-3042-2017 · C.R. Bard, Inc. · posted Aug 16, 2017 · Terminated
Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
- Z-3035-2017 · Magellan Diagnostics, Inc. · posted Aug 15, 2017 · Terminated
LeadCare II Test Kits controls out of range
- Z-3107-2017 · Cardinal Health 200, LLC · posted Aug 14, 2017 · Terminated
The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during…
- Brivo MR355, Optima MR360Class IIZ-3021-2017 · GE Medical Systems, LLC · posted Aug 2, 2017 · Terminated
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Optima MR450 1.5TClass IIZ-3022-2017 · GE Medical Systems, LLC · posted Aug 2, 2017 · Terminated
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Optima MR750 3.0TClass IIZ-3023-2017 · GE Medical Systems, LLC · posted Aug 2, 2017 · Terminated
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Optima MR450w 1.5TClass IIZ-3024-2017 · GE Medical Systems, LLC · posted Aug 2, 2017 · Terminated
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Discovery MR750 3.0TClass IIZ-3025-2017 · GE Medical Systems, LLC · posted Aug 2, 2017 · Terminated
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Z-3026-2017 · GE Medical Systems, LLC · posted Aug 2, 2017 · Terminated
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Z-3027-2017 · GE Medical Systems, LLC · posted Aug 2, 2017 · Terminated
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Z-3028-2017 · GE Medical Systems, LLC · posted Aug 2, 2017 · Terminated
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Signa PET/MR (K163619, K142098)Class IIZ-3029-2017 · GE Medical Systems, LLC · posted Aug 2, 2017 · Terminated
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.