Medtronic Inc.: CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator

Hazard

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Details from the source

Reason for recall: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. 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, Reu Quantity: 9 units Lot/code info: GTIN: 00763000178543, Serial Numbers: RSG601442S, RSG601443S, RSG601445S, RSG601446S, RSG601449S, RSG601461S, RSG601467S, RSG601478S; GTIN: 00763000711382, Serial Number: RSG601428S.

UPC codes

00763000178543, 00763000711382

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.