St. Jude Medical Recalls Proclaim DRG Implantable Pulse Generators
St. Jude Medical is recalling 17 Proclaim DRG Implantable Pulse Generators due to error messages during routine checks and transient overstimulation causing patient discomfort.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a defect (transient overstimulation) caused patient discomfort, but no serious injuries or deaths are reported in the source text.
Plain-English summary
St. Jude Medical, Inc. is recalling 17 units of the Proclaim DRG Implantable Pulse Generator, Model Number 3664. The recall involves specific lot and serial numbers distributed in the United States.
The firm initiated the recall after receiving complaints regarding error messages that occurred during routine impedance checks. Some of these complaints were also associated with transient overstimulation, which created discomfort for the patients.
Patients with these specific devices should contact their healthcare provider for further evaluation and instructions.
The recalled product
- Product
- Proclaim DRG Implantable Pulse Generator, Model Number 3664
- Manufacturer
- St. Jude Medical, Inc.
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- AVA214.1
- AVL027.1 Lot Number 6499208 Serial Numbers: AVD426.1
- AVA922.1 Lot Number 6263128 Serial Numbers: AVB119.1
- AVD400.1
- AVA622.1
- AVD431.1
- AVE633.1
- AVK678.1
- AVN837.1 Lot Number 6268723 Serial Numbers: AUV770.1
- AVW805.1 Lot Number 6278155 Serial Number AVK896.1
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · St. Jude Medical, Inc.
See all →- SevereSt Jude Medical Recalls 15 Ellipse DR Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 42 Ellipse DR Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 47 Ellipse VR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighSt. Jude Medical Proclaim DRG Implantable Pulse Generator Battery Indicator Recall
FDA (Devices) · 2017-10-25
- HighSt. Jude Medical Recalls Proclaim 7 Elite Implantable Pulse Generators
FDA (Devices) · 2017-07-19
- HighSt. Jude Medical Recalls Proclaim 5 Elite Implantable Pulse Generators
FDA (Devices) · 2017-07-19
- HighSt. Jude Medical Recalls Proclaim Elite Implantable Pulse Generators
FDA (Devices) · 2017-10-25
- HighSt. Jude Medical Recalls Infinity 5 and 7 Implantable Pulse Generators
FDA (Devices) · 2017-10-25
- HighSt. Jude Medical Recalls Infinity 5 Implantable Pulse Generators
FDA (Devices) · 2017-07-19