Medtronic Inc.: Medical Device Recall in 2024 - (Recall #: Z-2194-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator

Product Classification:

Class II

Date Initiated: April 16, 2024

Date Posted: July 3, 2024

Recall Number: Z-2194-2024

Event ID: 94674

Reason for Recall:

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

Status: Ongoing

Product Quantity: 58 units

Code Information:

GTIN: 00763000178093, Serial Number: RTC656756S; GTIN: 00763000178116, Serial Numbers: RTC656044S, RTC656047S, RTC656049S, RTC656061S, RTC656065S, RTC656070S, RTC656072S, RTC656099S, RTC656100S, RTC656102S, RTC656103S, RTC656104S, RTC656105S, RTC656106S, RTC656107S; GTIN: 00763000711160, Serial Numbers: RTC655925S, RTC655928S, RTC655930S, RTC655931S, RTC655932S, RTC655938S, RTC655945S, RTC655947S, RTC655950S, RTC655964S, RTC655971S, RTC656073S, RTC656074S, RTC656076S, RTC656077S, RTC656078S, RTC656080S, RTC656082S, RTC656087S, RTC656090S, RTC656093S, RTC656095S, RTC656096S, RTC656587S, RTC656589S, RTC656590S, RTC656592S, RTC656602S, RTC656603S, RTC656606S, RTC656607S, RTC656608S, RTC656609S, RTC656610S, RTC656615S, RTC656616S, RTC656619S, RTC656625S, RTC656626S, RTC656627S, RTC656628S, RTC656630S

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.

Voluntary or Mandated:

Voluntary: Firm initiated