Abbott is committed to presenting information with accuracy and integrity. As part of our effort to provide the most reliable and safe medical products, notices will be posted here when there is important information to share. If you have any questions or concerns, please contact your Abbott representative or Abbott Customer Service at 1-866-240-6741.
On November 11, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a single lot of Classic Radiofrequency Cannula—Curved (Model C-1005-S) were manufactured with a 10-mm active tip length instead of the labeled 5-mm active tip length. Please find the communication document below for further information.
Classic Radiofrequency Cannula - Curved Important Information - November 11, 2019
On October 14, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a select number of Radiofrequency Grounding Pads (Model RF-DGP-L) were manufactured with the protective release liner in an incorrect orientation. Please find the communication document below for further information.
Radiofrequency Grounding Pad Important Information – October 14, 2019
On October 29, 2018, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a select number of 8-Channel Leads for the St. Jude Medical Infinity™ DBS System may contain an electrode that was not manufactured to our material specification which causes it to appear lighter under radiography. Please find the below physician communication document with patient management recommendations for further information.
On October 11, 2018, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a select number of 8-Channel Leads for the St. Jude Medical Infinity™ DBS System may contain an electrode that was not manufactured to our material specification which causes it to appear lighter under radiography. Please find the below hospital communication documents for further information.
On March 14, 2018, Abbott provided an Important Medical Device Advisory to physicians regarding the Proclaim™ DRG (Dorsal Root Ganglion) Implantable Pulse Generator (IPG) Neurostimulator Systems (model: 3664).
Important Medical Device Advisory: Proclaim™ DRG Neurostimulation Impedence Error – March 14, 2018
On September 12, 2017, Abbott provided an Important Medical Device Advisory to physicians regarding the Proclaim™ SCS IPG devices, Proclaim™ DRG IPG devices and Infinity™ Deep Brain Stimulation (DBS) IPG devices in which a software calculation error has caused the elective replacement indicator (ERI) in some devices has triggered earlier than intended.
Read the Important Medical Device Advisory documents and FAQ documents for details regarding risk and patient management recommendations.
PROCLAIM™ SCS AND PROCLAIM™ DRG IPG DEVICES
INFINITY™ DEEP BRAIN STIMULATION (DBS) IPG DEVICES
ADDITIONAL RESOURCES
On June 2, 2017, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the St. Jude Medical implantable pulse generator (IPG) devices implanted before June 2, 2017, for Proclaim™ Elite SCS IPG (models: 3660 and 3662) and Infinity™ DBS IPG (models: 6660, 6661, 6662, and 6663).
On July 21, 2014, St. Jude Medical provided an update letter to physicians regarding Eon™ implantable pulse generators. This is an update to the previous voluntary device correction letter, dated December 19, 2011. See both physician letters and a patient safety information letter below:
Important Medical Device Correction Update: Eon™ Charging System – July 2014
Important Medical Device Safety Information: Eon™ Charging System – July 2014
On July 26, 2012, St. Jude Medical provided an update letter to physicians regarding the Eon Mini™ implantable pulse generator. This is an update to the previous voluntary recall notification letter, dated May 24, 2011. See both letters below:
Updated Medical Device Information: Eon Mini™ IPG – July 2012
Important Medical Device Information: Eon Mini™ IPG – May 2011
On July 21, 2012, St. Jude Medical provided an update letter to physicians regarding Eon™ and Eon Mini™ implantable pulse generators. This is an update to the previous voluntary device correction letter, dated December 19, 2011. See both physician letters and a patient safety information letter below:
Updated Medical Device Information: Eon™ and Eon Mini™ IPGs – July 2012
Important Medical Device Information: Eon™ and Eon Mini™ IPGs – December 2011
On December 19, 2011, St. Jude Medical provided a letter to physicians regarding the Eon Mini™ implantable pulse generator.
PDF Important Medical Device Information: Eon Mini™ IPG – December 2011
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