Recalls / —

—#208086

Product

Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator

FDA product code

LWS — Implantable Cardioverter Defibrillator (Non-Crt)

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P980016S713

Affected lot / code info

GTIN: 00763000178338, Serial Numbers: RSL607245S, RSL607881S, RSL607883S, RSL607884S, RSL607888S.

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Medtronic Inc.

Address

8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2024-04-16

Posted by FDA

2024-06-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #208086. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.