Z-2212-2024Class II
Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model...
Medtronic, Inc. / initiated 2024-04-16 / Open, Classified / root cause: manufacturing process
Medtronic Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2212-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic, Inc.
- 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, Model Number DTMC2QQ. i. EVERA MRI XT DR SureScan, Model Number DDMB2D4. j. VISIA AF MRI XT VR SureScan, Model Number DVFB2D1. k. VISIA AF MRI S VR SureScan, Model Number DVFC3D4. l. VISIA AF MRI XT VR SureScan, Model Number DVFB2D4.
- Product code
- LWS Implantable Cardioverter Defibrillator (Non-Crt)
- Reason for recall
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity in commerce
- 82 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- Product codes and lots
- 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2190-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2191-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2192-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2193-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2194-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2195-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2196-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2197-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2198-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2199-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2200-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2201-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2202-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2203-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2204-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2205-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2206-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2207-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2208-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2209-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2210-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2211-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2212-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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