Medtronic Inc. 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, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD CRT-D SureScan, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD CRT-D SureScan,
Brand
Medtronic Inc.
Lot Codes / Batch Numbers
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, Serial Numbers: RPG643295S, RPG643318S, GTIN 00763000611835, Serial Numbers: RPG643198S, RPG643199S, RPG643200S, RPG643203S, RPG643206S, RPG643209S, RPG643211S, RPG643213S, RPG643218S, RPG643219S, RPG643220S, RPG643221S, RPG643231S, RPG643251S. h. GTIN: 00763000206260, Serial Numbers: RPF648668S, RPF648672S, RPF648674S, RPF648675S, RPF648676S, RPF648677S, RPF648681S, RPF648684S, RPF648685S, RPF648686S, RPF648691S, RPF648693S, RPF648702S, RPF648758S, RPF648760S, RPF648761S, RPF648762S, RPF648763S, RPF648768S, RPF648769S, RPF648770S, RPF648771S, RPF648844S, RPF648846S, RPF648847S. i. GTIN: 00763000206147, Serial Numbers: PGZ663023S, PGZ663203S, PGZ663208S, PGZ663211S, PGZ663216S, PGZ663219S, PGZ663241S, PGZ663264S. j. GTIN: 00763000612191, Serial Numbers: CWH606546S, CWH606548S, CWH606551S, CWH606552S, CWH606553S. k. GTIN: 00763000206352, Serial Numbers: PMX622050S, PMX622052S, PMX622055S, PMX622056S, PMX622057S, PMX622059S. l. GTIN: 00763000206338, Serial Numbers: PLX622054S, PLX622056S, PLX622072S.
Products Sold
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, Serial Numbers: RPG643295S, RPG643318S; GTIN 00763000611835, Serial Numbers: RPG643198S, RPG643199S, RPG643200S, RPG643203S, RPG643206S, RPG643209S, RPG643211S, RPG643213S, RPG643218S, RPG643219S, RPG643220S, RPG643221S, RPG643231S, RPG643251S. h. GTIN: 00763000206260, Serial Numbers: RPF648668S, RPF648672S, RPF648674S, RPF648675S, RPF648676S, RPF648677S, RPF648681S, RPF648684S, RPF648685S, RPF648686S, RPF648691S, RPF648693S, RPF648702S, RPF648758S, RPF648760S, RPF648761S, RPF648762S, RPF648763S, RPF648768S, RPF648769S, RPF648770S, RPF648771S, RPF648844S, RPF648846S, RPF648847S. i. GTIN: 00763000206147, Serial Numbers: PGZ663023S, PGZ663203S, PGZ663208S, PGZ663211S, PGZ663216S, PGZ663219S, PGZ663241S, PGZ663264S. j. GTIN: 00763000612191, Serial Numbers: CWH606546S, CWH606548S, CWH606551S, CWH606552S, CWH606553S. k. GTIN: 00763000206352, Serial Numbers: PMX622050S, PMX622052S, PMX622055S, PMX622056S, PMX622057S, PMX622059S. l. GTIN: 00763000206338, Serial Numbers: PLX622054S, PLX622056S, PLX622072S.
Medtronic Inc. is recalling Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D due to Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Recommended Action
Per FDA guidance
On about 04/18/2024, Medtronic notified customers that they were retrieving distributed units that may have undergone a specific manufacturing sequence that requires additional engineering evaluation. They requested that customers acknowledge the letter with signature.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026