Medtronic Implantable Defibrillators Recalled for Manufacturing Weld Defect
Medtronic is recalling 82 implantable cardioverter defibrillators due to a manufacturing defect involving weld cracks discovered during quality control testing before distribution to patients.
What this means for you
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: Implantable cardiac devices are risk-of-harm products where device failure could have serious consequences. Although the manufacturing defect (weld crack) was caught during quality control testing before patient distribution, no illnesses or injuries have been reported. This meets the rubric criterion for High severity as a 'risk-of-harm product where injury has not yet been reported.'
Plain-English summary
Medtronic Inc. is recalling 82 units of multiple implantable cardioverter defibrillator (ICD) models distributed worldwide. The affected models include VIVA QUAD XT CRT-D, CLARIA MRI CRT-D SureScan, CLARIA MRI QUAD CRT-D SureScan, AMPLIA MRI CRT-D SureScan, AMPLIA MRI QUAD CRT-D SureScan, COMPIA MRI QUAD CRT-D SureScan, EVERA MRI XT DR SureScan, and VISIA AF MRI models.
A manufacturing defect involving a weld crack caused these devices to fail during the leak check step in manufacturing quality control. The defect was identified during this quality assurance process.
The 82 affected units were distributed in the United States (California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas, and Virginia) and internationally (including Canada, Australia, United Kingdom, and other countries worldwide).
The recalled product
- Product
- Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Mod
- Manufacturer
- Medtronic Inc.
- Hazard
- weld-crack
- manufacturing-defect
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 (20)
- a. GTIN: 00763000612269
- Serial Numbers: BLG628370S
- BLG628372S
- BLG628373S. b. GTIN: 00763000206284
- Serial Number: RPO606047S. c. GTIN: 00763000206222
- Serial Numbers: RPB629895S
- RPB629900S
- RPB629902S
- RPB629906S
- RPB629909S
- RPB629912S. d. GTIN: 00763000206307
- Serial Number: RPQ610208S. e. GTIN: 00763000206291
- Serial Numbers: RPK614721S
- RPK614728S. f. GTIN: 00763000206253
- Serial Numbers: RPP607499S
- RPP607504S
- RPP607517S
- RPP607518S
- RPP607522S
- RPP607586S. g. GTIN: 00763000206246
Distribution
Distributed nationwide across the United States.
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