Reported Jul 3, 2024 · Ongoing
Product not distributed in the US. Implantable Cardioverter Defibrillators
Medtronic Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc. · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
Product not distributed in the US. Implantable Cardioverter Defibrillators
12 of 12 products
| Model / number | Product as published |
|---|---|
DTBA2QQ. | VIVA QUAD XT CRT-D |
DTMA2D1. | CLARIA MRI CRT-D SureScan |
DTMA2QQ. | CLARIA MRI QUAD CRT-D SureScan |
DTMB2D1. | AMPLIA MRI CRT-D SureScan |
DTMB2D4. | AMPLIA MRI CRT-D SureScan |
DTMB2Q1. | AMPLIA MRI QUAD CRT-D SureScan |
DTMB2QQ. | AMPLIA MRI QUAD CRT-D SureScan |
DTMC2QQ. | COMPIA MRI QUAD CRT-D SureScan |
DDMB2D4. | EVERA MRI XT DR SureScan |
DVFB2D1. | VISIA AF MRI XT VR SureScan |
DVFC3D4. | VISIA AF MRI S VR SureScan |
DVFB2D4. | VISIA AF MRI XT VR SureScan |
- Lot codes and dates
12 of 12 products
Products covered by this recall Model / number Barcodes Product as published 00763000612269Serial Numbers: BLG628370S, BLG628372S, BLG628373S. 00763000206284Serial Number: RPO606047S. 00763000206222Serial Numbers: RPB629895S, RPB629900S, RPB629902S, RPB629906S, RPB629909S, RPB629912S. 00763000206307Serial Number: RPQ610208S. 00763000206291Serial Numbers: RPK614721S, RPK614728S. 00763000206253Serial Numbers: RPP607499S, RPP607504S, RPP607517S, RPP607518S, RPP607522S, RPP607586S. 0076300061183500763000206246GTIN: 00763000206246, Serial Numbers: RPG643295S, RPG643318S; , Serial Numbers: RPG643198S, RPG643199S, RPG643200S, RPG643203S, RPG643206S, RPG643209S, RPG643211S, RPG643213S, RPG643218S, RPG643219S, RPG643220S, RPG643221S, RPG643231S, RPG643251S. 00763000206260Serial 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. 00763000206147Serial Numbers: PGZ663023S, PGZ663203S, PGZ663208S, PGZ663211S, PGZ663216S, PGZ663219S, PGZ663241S, PGZ663264S. 00763000612191Serial Numbers: CWH606546S, CWH606548S, CWH606551S, CWH606552S, CWH606553S. 00763000206352Serial Numbers: PMX622050S, PMX622052S, PMX622055S, PMX622056S, PMX622057S, PMX622059S. 00763000206338Serial Numbers: PLX622054S, PLX622056S, PLX622072S. - Amount recalled
- 82 units
This recall covers 23 products
The agency filed one notice per product. You are reading one of them; the other 22 are below.
10 more are in the archive.
Where it was sold
Why it was recalled
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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